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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® Posterior Stabilized (PS) Knee Insert Kit
Conformis, Inc.
RPS010060002
In Commercial Distribution

  • M572RPS0100600021 ()

  • 6mm thick on the medial side, lateral side is patient specific
RPS0100600

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
iTotal® Posterior Stabilized (PS) Knee Replacement System
Conformis, Inc.
TPS111111102
In Commercial Distribution

  • M572TPS1111111021 ()

  • Patient Specific
TPS1111111

  • Total knee prosthesis implantation guide-instrument kit
  • Posterior-stabilized total knee prosthesis
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, MEDIAL, 14MM, LEFT
Conformis, Inc.
RCR010140014
In Commercial Distribution

  • M572RCR0101400141 ()
RCR-010-1400

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, MEDIAL, 14MM, LEFT & RIGHT
Conformis, Inc.
RCR010140004
In Commercial Distribution

  • M572RCR0101400041 ()
RCR-010-1400

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

  • M572RCR010130H011 ()
RCR-010-130H

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

  • M572RCR0101300141 ()
RCR-010-1300

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

  • M572RCR0101300041 ()
RCR-010-1300

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY, SINGLE, 12MM, LEFT & RIGHT
Conformis, Inc.
RCR010120G11
In Commercial Distribution

  • M572RCR010120G111 ()
RCR-010-120G

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY, SINGLE, 12MM, LEFT & RIGHT
Conformis, Inc.
RCR010120G01
In Commercial Distribution

  • M572RCR010120G011 ()
RCR-010-120G

  • Tibial insert
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