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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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iTotal Identity CR Knee Replacement System - M572RCR010000C041

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, LATERAL, C, LEFT & RIGHT
Conformis, Inc.
RCR010000C04
In Commercial Distribution

  • M572RCR010000C041 ()
RCR-010-000C

  • Tibial insert

iTotal Identity CR Knee Replacement System - M572RCR010000B141

ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, LATERAL, B, LEFT & RIGHT
Conformis, Inc.
RCR010000B04
In Commercial Distribution

  • M572RCR010000B141 ()
RCR-010-000B

  • Tibial insert

iTotal® CR iPoly® Insert Kit - M572RCR010000B131

N/A
Conformis, Inc.
RCR010000B13
In Commercial Distribution

  • M572RCR010000B131 ()

  • Patient Specific
RCR010000B

  • Tibial insert

iTotal Identity CR Knee Replacement System - M572RCR010000B041

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, LATERAL, B, LEFT & RIGHT
Conformis, Inc.
RCR010000B04
In Commercial Distribution

  • M572RCR010000B041 ()
RCR-010-000B

  • Tibial insert

iTotal Identity CR Knee Replacement System - M572RCR010000A141

ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, LATERAL, A, LEFT & RIGHT
Conformis, Inc.
RCR010000A14
In Commercial Distribution

  • M572RCR010000A141 ()
RCR-010-000A

  • Tibial insert

iTotal Identity CR Knee Replacement System - M572RCR010000A041

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, LATERAL, A, LEFT & RIGHT
Conformis, Inc.
RCR010000A04
In Commercial Distribution

  • M572RCR010000A041 ()
RCR-010-000A

  • Tibial insert

GUARDIAN® - M684250012201

GUARDIAN® TIBIAL SLEEVE POLY SPACER 20mm
Microport Orthopedics Inc.
25001220
In Commercial Distribution

  • 25001220 ()
  • M684250012201 ()

  • Height: 20 Millimeter
25001220

  • Tibial insert

GUARDIAN® - M684250012121

GUARDIAN® TIBIAL SLEEVE POLY SPACER 12mm
Microport Orthopedics Inc.
25001212
In Commercial Distribution

  • 25001212 ()
  • M684250012121 ()

  • Height: 12 Millimeter
25001212

  • Tibial insert

GUARDIAN® - M684250012081

GUARDIAN® TIBIAL SLEEVE POLY SPACER 8mm
Microport Orthopedics Inc.
25001208
In Commercial Distribution

  • 25001208 ()
  • M684250012081 ()

  • Height: 8 Millimeter
25001208

  • Tibial insert

iTotal Identity CR - M572RCR020000E041

ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, LATERAL, E, LEFT & RIGHT
Conformis, Inc.
RCR020000E04
In Commercial Distribution

  • M572RCR020000E041 ()
RCR-020-000E

  • Tibial insert
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