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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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Tibial Insert, Size 5, Left Medial, 10MM
Engage UNI LLC
1-10013-510
In Commercial Distribution

  • B6951100135100 ()


  • Unicondylar knee prosthesis
Tibial Insert, Size 5, Left Medial, 9MM
Engage UNI LLC
1-10013-509
In Commercial Distribution

  • B6951100135090 ()


  • Unicondylar knee prosthesis
FEMORAL CR, POROUS CoCr, SIZE 5, RIGHT
OPTIMOTION IMPLANTS LLC
1014-F-4502
In Commercial Distribution

  • B6961014F45020 ()


  • Cruciate-retaining total knee prosthesis
FEMORAL CR, POROUS CoCr, SIZE 5, LEFT
OPTIMOTION IMPLANTS LLC
1014-F-4501
In Commercial Distribution

  • B6961014F45010 ()


  • Cruciate-retaining total knee prosthesis
Tibial Tray Component, Porous Titanium, Size 5
OPTIMOTION IMPLANTS LLC
1014-B-1500
In Commercial Distribution

  • B6961014B15000 ()


  • Cruciate-retaining total knee prosthesis
K-WIRES (NS) KM172-15-62 K-WIRE .062 X 5"
Peter Brasseler Holdings, LLC
5004151M2
Not in Commercial Distribution

  • 00887919450832 ()


  • Orthopaedic bone pin, non-bioabsorbable
2.0 x 5 mm Self-Tapping Bone Screw
TMJ Solutions, Inc.
61-2005
In Commercial Distribution



  • Total temporomandibular joint prosthesis
KM169-49-56S 5/64 X 9" DBL DIAM
Peter Brasseler Holdings, LLC
5014452M0
In Commercial Distribution

  • 00887919588931 ()


  • Orthopaedic bone screw (non-sliding)
KM169-49-53S 5/32 X 9" DBL DIAM
Peter Brasseler Holdings, LLC
5014451M0
In Commercial Distribution

  • 00887919588924 ()


  • Orthopaedic bone screw (non-sliding)
KM169-39-56S 5/64 X 9" SGL DIAM
Peter Brasseler Holdings, LLC
5014445M0
In Commercial Distribution

  • 00887919588863 ()


  • Orthopaedic bone screw (non-sliding)
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