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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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Kosmo Femoral Hip System - 00843575110466

Standard Collared Hip Stem Size 9
B-ONE ORTHO, CORP.
8810101070
In Commercial Distribution

  • 00843575110466 ()
8810101070

  • Press-fit femoral stem prosthesis

MOBIO™ Total Knee System - 00843575107008

CR Femoral Trial, Size 9, Left
B-ONE ORTHO, CORP.
8829111091
In Commercial Distribution

  • 00843575107008 ()
8829111091

  • Knee femur prosthesis trial, reusable

MOBIO™ Total Knee System - 00843575107015

CR Femoral Trial, Size 9, Right
B-ONE ORTHO, CORP.
8829111092
In Commercial Distribution

  • 00843575107015 ()
8829111092

  • Knee femur prosthesis trial, reusable

MOBIO™ Total Knee System - 00843575104359

Spacer Block Size DE 9/10mm
B-ONE ORTHO, CORP.
8829211004
In Commercial Distribution

  • 00843575104359 ()
8829211004

  • Orthopaedic implant/instrument assembling device

Novel - 00844856034495

SD Cage Trial, Large, 9 mm
ALPHATEC SPINE, INC.
64887-009
In Commercial Distribution

  • 00844856034495 ()

  • Length: 28 Millimeter
  • Width: 9 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

Novel - 00844856034426

SD Cage Trial, Medium, 9 mm
ALPHATEC SPINE, INC.
64885-009
In Commercial Distribution

  • 00844856034426 ()

  • Width: 9 Millimeter
  • Height: 9 Millimeter
  • Length: 25 Millimeter


  • Spinal implant trial

Novel - 00844856034341

SD Cage Trial, Small, 9 mm
ALPHATEC SPINE, INC.
64883-009
In Commercial Distribution

  • 00844856034341 ()

  • Height: 9 Millimeter
  • Width: 9 Millimeter
  • Length: 22 Millimeter


  • Spinal implant trial

Novel - 00844856031432

SD Cage Trial, Large, 9 mm
ALPHATEC SPINE, INC.
64897-009
In Commercial Distribution

  • 00844856031432 ()

  • Length: 28 Millimeter
  • Width: 9 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

Novel - 00844856031364

SD Cage Trial, Medium, 9 mm
ALPHATEC SPINE, INC.
64895-009
In Commercial Distribution

  • 00844856031364 ()

  • Length: 25 Millimeter
  • Width: 9 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

Novel - 00844856031296

SD Cage Trial, Small, 9 mm
ALPHATEC SPINE, INC.
64893-009
In Commercial Distribution

  • 00844856031296 ()

  • Length: 22 Millimeter
  • Width: 9 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial
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