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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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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
Instrument, Plate Holder, Anterior Cervical Plating System (ACP)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-1001T-HOLD
In Commercial Distribution

  • 00814008024087 ()


  • General internal orthopaedic fixation system implantation kit
Instrument, Handle with Spin Cap, Anterior Cervical Plating System (ACP)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-1000T-500
In Commercial Distribution

  • 00814008024063 ()


  • General internal orthopaedic fixation system implantation kit
Instrument, Awl, Anterior Cervical Plating System (ACP)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-1001T-AWL
In Commercial Distribution

  • 00814008023943 ()


  • Bone awl, reusable
Caddy Lid, Anterior Cervical Interbody Fusion System (ACIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AC-1000C-103
In Commercial Distribution

  • 00814008023271 ()


  • Surgical instrument/implant rack
Caddy Base for 14X16 Implants, Anterior Cervical Interbody Fusion System (ACIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AC-1400C-102
In Commercial Distribution

  • 00814008023264 ()


  • Surgical instrument/implant rack
Caddy Base for 12X14 Implants, Anterior Cervical Interbody Fusion System (ACIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AC-1200C-102
In Commercial Distribution

  • 00814008023257 ()


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

  • 00814008023240 ()


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

  • 00814008023233 ()


  • Surgical instrument/implant rack
Instrument, Trial, Anterior Cervical Interbody Fusion System (ACIF)
NVISION BIOMEDICAL TECHNOLOGIES, INC.
AC-1416T-315
In Commercial Distribution

  • 00814008022908 ()

  • Height: 12 Millimeter
  • Length: 14 Millimeter
  • Width: 16 Millimeter
  • Angle: 6 degree


  • Surgical tamp, reusable
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