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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MIS Tulip Breaker. 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-006
In Commercial Distribution

  • 00814008025688 ()


  • General internal orthopaedic fixation system implantation kit
MIS Dilator Driver. 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-008
In Commercial Distribution

  • 00814008025671 ()


  • General internal orthopaedic fixation system implantation kit
MIS Final Dilator, Threaded. 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-005
In Commercial Distribution

  • 00814008025664 ()


  • General internal orthopaedic fixation system implantation kit
Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block
TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block
Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block
Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block
THREADED GRAFT SQUARE
MEDTRONIC SOFAMOR DANEK, INC.
X0596-011
In Commercial Distribution

  • 00673978140513 ()


  • Bone graft packing block
THREADED GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0596-010
In Commercial Distribution

  • 00673978140506 ()


  • Bone graft packing block
BLOCK EX0917036 S.S. LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
EX0917036
In Commercial Distribution

  • 00763000134679 ()


  • Bone graft packing block
STATION X0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0516086
In Commercial Distribution

  • 00763000177669 ()


  • Bone graft packing block
STATION X0314002 DUL SIDED GRFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0314002
In Commercial Distribution

  • 00763000177645 ()


  • Bone graft packing block
BLOCK 4680011 LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
4680011
In Commercial Distribution

  • 00763000194000 ()


  • Bone graft packing block
STATION EX0718010 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0718010
In Commercial Distribution

  • 00763000186319 ()


  • Bone graft packing block
PACKING STATION EX0818003 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0818003
In Commercial Distribution

  • 00763000216948 ()


  • Bone graft packing block
STATION EX0420049 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0420049
In Commercial Distribution

  • 00763000387068 ()


  • Bone graft packing block
STATION EX0220045 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0220045
In Commercial Distribution

  • 00763000371777 ()


  • Bone graft packing block
IMPACTOR X807-914 ANGLED GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
X807-914
In Commercial Distribution

  • 00673978158327 ()


  • Bone graft packing block
IMPACTOR EX0711465 ANGLED GRAFT W/ TAB
MEDTRONIC SOFAMOR DANEK, INC.
EX0711465
In Commercial Distribution

  • 00643169050709 ()


  • Bone graft packing block
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