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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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Grappler Knotless Anchor, PEEK, ø5.5 x 15mm, Anchor/Driver only, Sterile Kit
Paragon 28, Inc.
P44-131-5515-SK
In Commercial Distribution

  • 00889795123923 ()
P44-131-5515-SK

  • General internal orthopaedic fixation system implantation kit
Grappler Knotless Anchor, PEEK, ø4.5 x 15mm, Anchor/Driver only, Sterile Kit
Paragon 28, Inc.
P44-131-4515-SK
In Commercial Distribution

  • 00889795123916 ()
P44-131-4515-SK

  • General internal orthopaedic fixation system implantation kit
No Description
INTERVENTIONAL SPINE, INC
6004
In Commercial Distribution

  • 00811954012656 ()
6004

  • General internal orthopaedic fixation system implantation kit
  • Orthopaedic implant driver
No Description
INTERVENTIONAL SPINE, INC
6095
In Commercial Distribution

  • 81195401040924 ()
6095

  • General internal orthopaedic fixation system implantation kit
  • Orthopaedic implant driver
No Description
ARTHREX, INC.
Jones Bolt Actuation Driver, Disposable
Not in Commercial Distribution

  • 00816988013136 ()
CS7200

  • General internal orthopaedic fixation system implantation kit
SpineNet SSP® Cam Lock Driver-Instrument
SPINENET, LLC
SpineNet SSP® Cam-Lock Driver
In Commercial Distribution

  • B047106110 ()
106-11

  • General internal orthopaedic fixation system implantation kit
No Description
ARTHREX, INC.
Jones Bolt Actuation Driver Shaft, Reusable
Not in Commercial Distribution

  • 00816988013082 ()
IN7210

  • 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
Open Pedical 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-060
In Commercial Distribution

  • 00814008026074 ()


  • General internal orthopaedic fixation system implantation kit
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