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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Fixed Ang Driver Outer Assembly
NEXXT SPINE, LLC
138N4015
In Commercial Distribution

  • 00840067206485 ()


  • General internal orthopaedic fixation system implantation kit
Fixed Ang T10 Driver, Short
NEXXT SPINE, LLC
138N4013
In Commercial Distribution

  • 00840067206324 ()


  • General internal orthopaedic fixation system implantation kit
Poly Angle Driver, Self Guided
NEXXT SPINE, LLC
138N4042
In Commercial Distribution

  • 00840067206294 ()


  • General internal orthopaedic fixation system implantation kit
Poly Angle Driver
NEXXT SPINE, LLC
138N4033
In Commercial Distribution

  • 00840067206270 ()


  • General internal orthopaedic fixation system implantation kit
TrellOss™-C SA Straight Driver
NEXXT SPINE, LLC
138N4023
In Commercial Distribution

  • 00840067205334 ()


  • General internal orthopaedic fixation system implantation kit
Specialty Xia 3 Driver with A/O Connection
Stryker Corporation
IS4385XLP
In Commercial Distribution

  • 07613327461367 ()
IS4385XLP

  • General internal orthopaedic fixation system implantation kit
Specialty Xia 3 Long Driver
Stryker Corporation
IS4397XLP01
In Commercial Distribution

  • 07613327424058 ()
IS4397XLP01

  • General internal orthopaedic fixation system implantation kit
Specialty Xia 4.5 Long Driver
Stryker Corporation
IS4397XLP02
In Commercial Distribution

  • 07613327424041 ()
IS4397XLP02

  • General internal orthopaedic fixation system implantation kit
Cross Connector Screw 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-108
In Commercial Distribution

  • 00814008029754 ()


  • General internal orthopaedic fixation system implantation kit
Set Screw Driver (Double End). 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-061
In Commercial Distribution

  • 00814008026081 ()


  • General internal orthopaedic fixation system implantation kit
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