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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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Ø7.0 x 55mm CANNULATED FULL THREAD SCREW
Osteocentric Technologies, Inc.
370-5055-001
In Commercial Distribution

  • 00816950026416 ()

  • Length: 55 Millimeter
370-5055-001

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ø7.0 x 24mm x 55mm CANNULATED PARTIAL THREAD SCREW
Osteocentric Technologies, Inc.
370-5055-024
In Commercial Distribution

  • 00816950026706 ()

  • Length: 55 Millimeter
370-5055-024

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Anterior Cervical Plating System, 4.75mm dia. 10mm long variable screw
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-475-10V
In Commercial Distribution

  • 90814008023786 ()

  • Height: 10 Millimeter
  • Width: 4.75 Millimeter
  • Depth: 4.75 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4.25mm dia. 10mm long variable scew
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-10V
In Commercial Distribution

  • 90814008023731 ()

  • Height: 10 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 3.75mm dia. 10mm long variable screw
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-375-10V
In Commercial Distribution

  • 90814008023670 ()

  • Height: 10 Millimeter
  • Width: 3.75 Millimeter
  • Depth: 3.75 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4.25mm dia. 10mm long fixed screw
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-10F
In Commercial Distribution

  • 90814008023618 ()

  • Height: 10 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 3.75mm dia. 10mm long fixed screw
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-375-10F
In Commercial Distribution

  • 90814008023557 ()

  • Height: 10 Millimeter
  • Width: 3.75 Millimeter
  • Depth: 3.75 Millimeter


  • Intervertebral-body internal spinal fixation system
primaLOK SP 10mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0110-00
In Commercial Distribution

  • 00813210021747 ()

  • Height: 10 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
silicone soft tissue facial implant
SURGISIL, LLP
PFI 5055
Not in Commercial Distribution

  • 00853437006066 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5 Millimeter


  • Malar prosthesis
TLIF Encoded 11x35 10mm 7 Degree
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TLE-710-T
In Commercial Distribution

  • 90814008025254 ()

  • Length: 11 Millimeter
  • Width: 35 Millimeter
  • Height: 10 Millimeter
  • Angle: 7 degree
  • 11x35 Lordotic 10mm 7 degree


  • Polymeric spinal interbody fusion cage
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