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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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Ambition Knee System - 00840286838320

Tibial Insert, PS, VitalitE, 3, 18mm
Shalby Advanced Technologies, Inc.
5100-0-1318
In Commercial Distribution

  • 00840286838320 ()
5100-0-1318

  • Tibial insert

Ambition Knee System - 00840286838313

Tibial Insert, PS, VitalitE, 3, 16mm
Shalby Advanced Technologies, Inc.
5100-0-1316
In Commercial Distribution

  • 00840286838313 ()
5100-0-1316

  • Tibial insert

Ambition Knee System - 00840286838306

Tibial Insert, PS, VitalitE, 3, 14mm
Shalby Advanced Technologies, Inc.
5100-0-1314
In Commercial Distribution

  • 00840286838306 ()
5100-0-1314

  • Tibial insert

Ambition Knee System - 00840286838290

Tibial Insert, PS, VitalitE, 3, 12mm
Shalby Advanced Technologies, Inc.
5100-0-1312
In Commercial Distribution

  • 00840286838290 ()
5100-0-1312

  • Tibial insert

Ambition Knee System - 00840286838283

Tibial Insert, PS, VitalitE, 3, 10mm
Shalby Advanced Technologies, Inc.
5100-0-1310
In Commercial Distribution

  • 00840286838283 ()
5100-0-1310

  • Tibial insert

iTotal® Identity Cruciate Retaining Knee Replacement System - M572RCR010130H111

ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, SINGLE, 13MM, LEFT & RIGHT
Conformis, Inc.
RCR010130H11
In Commercial Distribution

  • M572RCR010130H111 ()
RCR-010-130H

  • Tibial insert

iTotal® Identity Cruciate Retaining Knee Replacement System - M572RCR010130H011

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, SINGLE, 13MM, LEFT & RIGHT
Conformis, Inc.
RCR010130H01
In Commercial Distribution

  • M572RCR010130H011 ()
RCR-010-130H

  • Tibial insert

iTotal® Identity Cruciate Retaining Knee Replacement System - M572RCR0101300141

ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, MEDIAL, 13MM, LEFT
Conformis, Inc.
RCR010130014
In Commercial Distribution

  • M572RCR0101300141 ()
RCR-010-1300

  • Tibial insert

iTotal® CR iPoly® Insert Kit - M572RCR0101300131

N/A
Conformis, Inc.
RCR010130013
In Commercial Distribution

  • M572RCR0101300131 ()

  • Height: 13 Millimeter
RCR0101300

  • Tibial insert

iTotal® Identity Cruciate Retaining Knee Replacement System - M572RCR0101300041

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, MEDIAL, 13MM, LEFT & RIGHT
Conformis, Inc.
RCR010130004
In Commercial Distribution

  • M572RCR0101300041 ()
RCR-010-1300

  • Tibial insert
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