Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2101-31-01-NS
In Commercial Distribution

  • 10650551092886 ()
  • 00650551092889 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-31-01-NS

  • Depth electrode
CRIMPING TOOL FOR NON-CRIMPED SPHENOIDAL ELECTRODE
PMT CORPORATION
2105
In Commercial Distribution

  • 00650551092797 ()
2105

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 40 MICROWIRE CONTACTS, 2 X 32 POSITION CONNECTORS
PMT CORPORATION
2104-24-40-002-NS
In Commercial Distribution

  • 00650551096047 ()

  • Main Tube Length 7.3 Centimeter
  • Microwire Diameter 25 Micrometer
  • Contact Size 2 & 0.5 Millimeter
2104-24-40-002-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 12 MICROWIRE CONTACTS, INLINE TAILS WITH 10CM LEADS
PMT CORPORATION
2104-14-12-001-NS
In Commercial Distribution

  • 00650551096030 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 25 Centimeter
2104-14-12-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CONTACTS, INLINE TAILS WITH 10CM LEADS
PMT CORPORATION
2104-12-10-001-NS
In Commercial Distribution

  • 00650551096023 ()

  • Main Tube Length 20 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-12-10-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 14 MICROWIRE CONTACTS, INLINE CONNECTOR WITH 10CM LEAD
PMT CORPORATION
2104-10-14-001-NS
In Commercial Distribution

  • 00650551096016 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 24 Centimeter
2104-10-14-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 4 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-10-04-003-NS
In Commercial Distribution

  • 00650551096009 ()

  • Main Tube Length 22 Centimeter
  • Microwire Diameter 75 Micrometer
  • Contact Size 2 Millimeter
2104-10-04-003-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-08-16-001-NS
In Commercial Distribution

  • 00650551095996 ()

  • Contact Size 1.4 Millimeter
  • Microwire Diameter 40 Micrometer
2104-08-16-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-08-08-003-NS
In Commercial Distribution

  • 00650551095989 ()

  • Main Tube Length 32 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-08-08-003-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-08-08-002-NS
In Commercial Distribution

  • 00650551095972 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 32 Centimeter
2104-08-08-002-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS WITH 10CM LEAD
PMT CORPORATION
2104-04-16-03-104-NS
In Commercial Distribution

  • 00650551095965 ()

  • Main Tube Length 30 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-04-16-03-104-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS WITH 10CM LEAD
PMT CORPORATION
2104-04-16-03-103-NS
In Commercial Distribution

  • 00650551095958 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
2104-04-16-03-103-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-03-102-NS
In Commercial Distribution

  • 00650551095941 ()

  • Main Tube Length 30 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-04-16-03-102-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-053-NS
In Commercial Distribution

  • 00650551095934 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
  • Contact Size 2 Millimeter
2104-04-16-02-053-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-052-NS
In Commercial Distribution

  • 00650551095927 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
2104-04-16-02-052-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-00-08-009-NS
In Commercial Distribution

  • 00650551095910 ()

  • Main Tube Length 15 Centimeter
  • Microwire Diameter 25 Micrometer
2104-00-08-009-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-08-099-NS
In Commercial Distribution

  • 00650551069119 ()

  • Main Tube Length 30.5 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 37 Millimeter
  • Spacing 5 Millimeter
2102-08-099-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-08-080-NS
In Commercial Distribution

  • 00650551069096 ()

  • Main Tube Length 32 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 37 Millimeter
  • Spacing 5 Millimeter
2102-08-080-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-08-041-NS
In Commercial Distribution

  • 00650551069072 ()

  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
  • Recording Depth 75 Millimeter
  • Spacing 10 Millimeter
2102-08-041-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-08-039-NS
In Commercial Distribution

  • 00650551069058 ()

  • Spacing 4.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
2102-08-039-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-08-037-NS
In Commercial Distribution

  • 00650551069034 ()

  • Spacing 5 Millimeter
  • Recording Depth 37 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 36 Centimeter
2102-08-037-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, INLINE CONNECTOR, MEG 2
PMT CORPORATION
2102-08-023M2-NS
In Commercial Distribution

  • 00650551069010 ()

  • Main Tube Length 67 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 37 Millimeter
  • Spacing 5 Millimeter
2102-08-023M2-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-036-NS
In Commercial Distribution

  • 00650551068679 ()

  • Main Tube Length 36 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 17 Millimeter
  • Spacing 5 Millimeter
2102-04-036-NS

  • Depth electrode
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit
Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block
PS, MIS-Extend, Cannulated Dual Lead 6.5X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-060
In Commercial Distribution

  • 00814008028320 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-055
In Commercial Distribution

  • 00814008028313 ()

  • Length: 55 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-050
In Commercial Distribution

  • 00814008028306 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-045
In Commercial Distribution

  • 00814008028290 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-040
In Commercial Distribution

  • 00814008028283 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X35mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-035
In Commercial Distribution

  • 00814008028276 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-030
In Commercial Distribution

  • 00814008028269 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 6.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-650-025
In Commercial Distribution

  • 00814008028252 ()

  • Length: 25 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-060
In Commercial Distribution

  • 00814008028245 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-055
In Commercial Distribution

  • 00814008028238 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-050
In Commercial Distribution

  • 00814008028221 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-045
In Commercial Distribution

  • 00814008028214 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-040
In Commercial Distribution

  • 00814008028207 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X35mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-035
In Commercial Distribution

  • 00814008028191 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-030
In Commercial Distribution

  • 00814008028184 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 5.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-550-025
In Commercial Distribution

  • 00814008028177 ()

  • Length: 25 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-475-060
In Commercial Distribution

  • 00814008028160 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-475-055
In Commercial Distribution

  • 00814008028153 ()

  • Length: 55 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-475-050
In Commercial Distribution

  • 00814008028146 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-475-045
In Commercial Distribution

  • 00814008028139 ()

  • Length: 45 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Extend, Cannulated Dual Lead 4.75X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDM-475-040
In Commercial Distribution

  • 00814008028122 ()

  • Outer Diameter: 4.75 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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