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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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Novel - 00844856008441

NOVEL-LCC 10 x 20 x 12mm FLAT
ALPHATEC SPINE, INC.
64103-012
In Commercial Distribution

  • 00844856008441 ()

  • Length: 20 Millimeter
  • Height: 12 Millimeter
  • Width: 10 Millimeter


  • Vertebral body prosthesis
  • Polymeric spinal interbody fusion cage

Novel - 00844856008434

NOVEL-LCC 10 x 20 x 10mm FLAT
ALPHATEC SPINE, INC.
64103-010
In Commercial Distribution

  • 00844856008434 ()

  • Width: 10 Millimeter
  • Length: 20 Millimeter
  • Height: 10 Millimeter


  • Vertebral body prosthesis
  • Polymeric spinal interbody fusion cage

Novel - 00844856008427

NOVEL-LCC 10 x 20 x 8mm FLAT
ALPHATEC SPINE, INC.
64103-008
In Commercial Distribution

  • 00844856008427 ()

  • Length: 20 Millimeter
  • Width: 10 Millimeter
  • Height: 8 Millimeter


  • Vertebral body prosthesis
  • Polymeric spinal interbody fusion cage

VERTEX® Reconstruction System - 00613994356796

SCREW 6958720PT 3.5MM X 20 PT MAS
MEDTRONIC SOFAMOR DANEK, INC.
6958720PT
In Commercial Distribution

  • 00613994356796 ()


  • Spinal bone screw, non-bioabsorbable

CS2 Acet. Cup Sys. - VitalitE - 00844588019340

Acet. Insert, Lat. +5mm, 20° Hood, VitalitE
CONSENSUS ORTHOPEDICS, INC.
1166-0-3268
Not in Commercial Distribution

  • 00844588019340 ()

  • Outer Diameter: 32 Millimeter
1166-0-3268

  • Non-constrained polyethylene acetabular liner

CS2 Acet. Cup Sys. - VitalitE - 00844588019333

Acet. Insert, Lat. +5mm, 20° Hood, VitalitE
CONSENSUS ORTHOPEDICS, INC.
1166-0-3266
Not in Commercial Distribution

  • 00844588019333 ()

  • Outer Diameter: 32 Millimeter
1166-0-3266

  • Non-constrained polyethylene acetabular liner

CS2 Acet. Cup Sys. - VitalitE - 00844588019326

Acet. Insert, Lat. +5mm, 20° Hood, VitalitE
CONSENSUS ORTHOPEDICS, INC.
1166-0-3264
Not in Commercial Distribution

  • 00844588019326 ()

  • Outer Diameter: 32 Millimeter
1166-0-3264

  • Non-constrained polyethylene acetabular liner

CS2 Acet. Cup Sys. - VitalitE - 00844588019319

Acet. Insert, Lat. +5mm, 20° Hood, VitalitE
CONSENSUS ORTHOPEDICS, INC.
1166-0-3262
Not in Commercial Distribution

  • 00844588019319 ()

  • Outer Diameter: 32 Millimeter
1166-0-3262

  • Non-constrained polyethylene acetabular liner

CS2 Acet. Cup Sys. - VitalitE - 00844588019302

Acet. Insert, Lat. +5mm, 20° Hood, VitalitE
CONSENSUS ORTHOPEDICS, INC.
1166-0-3260
Not in Commercial Distribution

  • 00844588019302 ()

  • Outer Diameter: 32 Millimeter
1166-0-3260

  • Non-constrained polyethylene acetabular liner

CS2 Acet. Cup Sys. - VitalitE - 00844588019296

Acet. Insert, Lat. +5mm, 20° Hood, VitalitE
CONSENSUS ORTHOPEDICS, INC.
1166-0-3258
Not in Commercial Distribution

  • 00844588019296 ()

  • Outer Diameter: 32 Millimeter
1166-0-3258

  • Non-constrained polyethylene acetabular liner
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