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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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Healix - 00810005662826

4.0 Instrument Caddy. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CS-1200C-115
In Commercial Distribution

  • 00810005662826 ()


  • Surgical instrument/implant rack

Trigon - 00810005669894

Trigon Subtalar Wedge Case Assembly. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001C-200
In Commercial Distribution

  • 00810005669894 ()


  • Surgical instrument/implant rack

Vector - 00810005666596

Surgical case for holding instruments. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-1001C-101
In Commercial Distribution

  • 00810005666596 ()

  • Height: 1.319 Inch
  • Width: 3.35 Inch
  • Length: 6.50 Inch


  • Surgical instrument/implant rack

Focus - 00810005664912

Caddy 8.5 Screws. 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-1000C-850
In Commercial Distribution

  • 00810005664912 ()


  • Surgical instrument/implant rack

Focus - 00810005664905

Caddy 7.5 Screws. 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-1000C-750
In Commercial Distribution

  • 00810005664905 ()


  • Surgical instrument/implant rack

Focus - 00810005664899

Caddy 6.5 Screws. 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-1000C-650
In Commercial Distribution

  • 00810005664899 ()


  • Surgical instrument/implant rack

Javelin - 00810005663977

Javelin Screw Caddy Body. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000C-103
In Commercial Distribution

  • 00810005663977 ()


  • Surgical instrument/implant rack

TALOS® IBF - B167100909300

No Description
MEDITECH SPINE, LLC
100-909-30
In Commercial Distribution

  • B167100909300 ()


  • Surgical instrument/implant rack

TALOS® IBF - B167100909260

No Description
MEDITECH SPINE, LLC
100-909-26
In Commercial Distribution

  • B167100909260 ()


  • Surgical instrument/implant rack

TALOS® IBF - B167100909220

No Description
MEDITECH SPINE, LLC
100-909-22
In Commercial Distribution

  • B167100909220 ()


  • Surgical instrument/implant rack
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