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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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Paddle Shavers, Posterior Lumbar Interbody Fusion System (PLIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PL-1000T-708
In Commercial Distribution

  • 00814008021161 ()

  • Height: 8 Millimeter


  • Bone file/rasp, manual, reusable
Paddle Shavers, Posterior Lumbar Interbody Fusion System (PLIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PL-1000T-707
In Commercial Distribution

  • 00814008021154 ()

  • Height: 7 Millimeter


  • Bone file/rasp, manual, reusable
Paddle Shavers, Posterior Lumbar Interbody Fusion System (PLIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PL-1000T-706
In Commercial Distribution

  • 00814008021147 ()

  • Height: 6 Millimeter


  • Bone file/rasp, manual, reusable
Instrument, Slap Hammer, Posterior Lumbar Interbody Fusion System (PLIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PL-1000T-400
In Commercial Distribution

  • 00814008021123 ()


  • Surgical mallet
Instrument, Straight Inserter, Posterior Lumbar Interbody Fusion System (PLIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PL-1000T-100
In Commercial Distribution

  • 00814008021116 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Caddy Lid, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000C-105
In Commercial Distribution

  • 00814008020621 ()


  • Surgical instrument/implant rack
Caddy Base for 29 X 39 implants, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2900C-102
In Commercial Distribution

  • 00814008020591 ()


  • Surgical instrument/implant rack
Caddy Base for 25 X 34 implants, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2500C-102
In Commercial Distribution

  • 00814008020584 ()


  • Surgical instrument/implant rack
ALIF Tray 2, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000C-104
In Commercial Distribution

  • 00814008020577 ()


  • Surgical instrument/implant rack
ALIF Tray 1, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000C-103
In Commercial Distribution

  • 00814008020560 ()


  • Surgical instrument/implant rack
Case Lid, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000C-102
In Commercial Distribution

  • 00814008020553 ()


  • Surgical instrument/implant rack
Case Base, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000C-101
In Commercial Distribution

  • 00814008020546 ()


  • Surgical instrument/implant rack
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-1220
In Commercial Distribution

  • 00814008020539 ()

  • Height: 20 Millimeter
  • Angle: 12 degree
  • Length: 29 Millimeter
  • Width: 39 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-1218
In Commercial Distribution

  • 00814008020522 ()

  • Width: 39 Millimeter
  • Length: 29 Millimeter
  • Angle: 12 degree
  • Height: 18 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-1216
In Commercial Distribution

  • 00814008020515 ()

  • Height: 16 Millimeter
  • Angle: 12 degree
  • Length: 29 Millimeter
  • Width: 39 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-1214
In Commercial Distribution

  • 00814008020508 ()

  • Width: 39 Millimeter
  • Length: 29 Millimeter
  • Angle: 12 degree
  • Height: 14 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-1212
In Commercial Distribution

  • 00814008020492 ()

  • Height: 12 Millimeter
  • Angle: 12 degree
  • Length: 29 Millimeter
  • Width: 39 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-1210
In Commercial Distribution

  • 00814008020485 ()

  • Width: 39 Millimeter
  • Length: 29 Millimeter
  • Angle: 12 degree
  • Height: 10 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-0620
In Commercial Distribution

  • 00814008020478 ()

  • Height: 20 Millimeter
  • Angle: 6 degree
  • Length: 29 Millimeter
  • Width: 39 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-0618
In Commercial Distribution

  • 00814008020461 ()

  • Width: 39 Millimeter
  • Length: 29 Millimeter
  • Angle: 6 degree
  • Height: 18 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-0616
In Commercial Distribution

  • 00814008020454 ()

  • Height: 16 Millimeter
  • Angle: 6 degree
  • Length: 29 Millimeter
  • Width: 39 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-0614
In Commercial Distribution

  • 00814008020447 ()

  • Width: 39 Millimeter
  • Length: 29 Millimeter
  • Angle: 6 degree
  • Height: 14 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-0612
In Commercial Distribution

  • 00814008020430 ()

  • Height: 12 Millimeter
  • Angle: 6 degree
  • Length: 29 Millimeter
  • Width: 39 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2939T-0610
In Commercial Distribution

  • 00814008020423 ()

  • Width: 39 Millimeter
  • Length: 29 Millimeter
  • Angle: 6 degree
  • Height: 10 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2534T-1220
In Commercial Distribution

  • 00814008020416 ()

  • Height: 20 Millimeter
  • Angle: 12 degree
  • Length: 25 Millimeter
  • Width: 34 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2534T-1218
In Commercial Distribution

  • 00814008020409 ()

  • Width: 34 Millimeter
  • Length: 25 Millimeter
  • Angle: 12 degree
  • Height: 18 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2534T-1216
In Commercial Distribution

  • 00814008020393 ()

  • Height: 16 Millimeter
  • Angle: 12 degree
  • Length: 25 Millimeter
  • Width: 34 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2534T-1214
In Commercial Distribution

  • 00814008020386 ()

  • Width: 34 Millimeter
  • Length: 25 Millimeter
  • Angle: 12 degree
  • Height: 14 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2534T-1212
In Commercial Distribution

  • 00814008020379 ()

  • Height: 12 Millimeter
  • Angle: 12 degree
  • Length: 25 Millimeter
  • Width: 34 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2534T-1210
In Commercial Distribution

  • 00814008020362 ()

  • Width: 34 Millimeter
  • Length: 25 Millimeter
  • Angle: 12 degree
  • Height: 10 Millimeter


  • Surgical tamp, reusable
Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-2534T-0620
In Commercial Distribution

  • 00814008020355 ()

  • Height: 20 Millimeter
  • Angle: 6 degree
  • Length: 25 Millimeter
  • Width: 34 Millimeter


  • Surgical tamp, reusable
Instrument, Rasp Distractor Tip - Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000T-303
In Commercial Distribution

  • 00814008020287 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument, Distractor Tip - Small, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000T-302
In Commercial Distribution

  • 00814008020270 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument, Parallel Distractor, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000T-300
In Commercial Distribution

  • 00814008020263 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument, Trans-anterior Inserter Shaft, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000T-102
In Commercial Distribution

  • 00814008020256 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument, Straight Inserter, Anterior Lumbar Interbody Fusion System (ALIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AL-1000T-100
In Commercial Distribution

  • 00814008020249 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Tower Dis-Engage Instrument. 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.
PD-1000T-110
In Commercial Distribution

  • 00814008029822 ()


  • General internal orthopaedic fixation system implantation kit
Small Ratcheting T-Handle. 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.
PD-1000T-109
In Commercial Distribution

  • 00814008029815 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: CC Wedge Inserter. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CCI
In Commercial Distribution

  • 00814008029785 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Awl Small. 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.
PD-1000T-112
In Commercial Distribution

  • 00814008029778 ()


  • General internal orthopaedic fixation system implantation kit
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