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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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ROI-C - 03662663016490

ROI-C Lordotic Implant 14x17H8
LDR Spine Usa, Inc.
MC1434P
In Commercial Distribution

  • 03662663016490 ()

  • Width: 17 Millimeter
  • Depth: 14 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal fusion cage, sterile

Balanced Knee System - 00822409009657

Size 4 8mm Tibial Insert CR
Ortho Development Corporation
163-2408
In Commercial Distribution

  • 00822409009657 ()

  • Height: 8 Millimeter


  • Tibial insert

Balanced Knee System - 00822409009541

Size 3 8mm Tibial Insert CR
Ortho Development Corporation
163-2308
In Commercial Distribution

  • 00822409009541 ()

  • Height: 8 Millimeter


  • Tibial insert

ROI-C - 03662663016308

ROI-C IMPLANT 12X14 H8
LDR Spine Usa, Inc.
MC1344P
In Commercial Distribution

  • 03662663016308 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal fusion cage, sterile

Balanced Knee System - 00822409009435

Size 2 8mm Tibial Insert CR
Ortho Development Corporation
163-2208
In Commercial Distribution

  • 00822409009435 ()

  • Height: 8 Millimeter


  • Tibial insert

ROI-C - 03662663016162

ROI-C IMPLANT 14X15.5 H8
LDR Spine Usa, Inc.
MC1324P
In Commercial Distribution

  • 03662663016162 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal fusion cage, sterile

Balanced Knee System - 00822409009329

Size 1 8mm Tibial Insert CR
Ortho Development Corporation
163-2108
In Commercial Distribution

  • 00822409009329 ()

  • Height: 8 Millimeter


  • Tibial insert

Balanced Knee System - 00822409009213

Size 7 8mm Tibial Insert PS
Ortho Development Corporation
163-1708
In Commercial Distribution

  • 00822409009213 ()

  • Height: 8 Millimeter


  • Tibial insert

Balanced Knee System - 00822409009107

Size 6 8mm Tibial Insert PS
Ortho Development Corporation
163-1608
In Commercial Distribution

  • 00822409009107 ()

  • Height: 8 Millimeter


  • Tibial insert

Balanced Knee System - 00822409008995

Size 5 8mm Tibial Insert PS
Ortho Development Corporation
163-1508
In Commercial Distribution

  • 00822409008995 ()

  • Height: 8 Millimeter


  • Tibial insert
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