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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 CR–IPOLY XE–LATERAL E INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000E03
In Commercial Distribution

  • M572RCR020000E031 ()

  • Thickness 10mm
RCR-020-000E

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, D, LEFT & RIGHT
Conformis, Inc.
RCR020000D14
In Commercial Distribution

  • M572RCR020000D141 ()
RCR-020-000D

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL D INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000D13
In Commercial Distribution

  • M572RCR020000D131 ()

  • Patient Specific
RCR020000D

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, LATERAL, D, LEFT & RIGHT
Conformis, Inc.
RCR020000D04
In Commercial Distribution

  • M572RCR020000D041 ()
RCR-020-000D

  • Tibial insert
ITOTAL CR–IPOLY XE–LATERAL D INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000D03
In Commercial Distribution

  • M572RCR020000D031 ()

  • Thickness 9mm
RCR-020-000D

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, C, LEFT & RIGHT
Conformis, Inc.
RCR020000C14
In Commercial Distribution

  • M572RCR020000C141 ()
RCR-020-000C

  • Tibial insert
N/A
Conformis, Inc.
RCR020000C13
In Commercial Distribution

  • M572RCR020000C131 ()

  • Patient Specific
RCR020000C

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, LATERAL, C, LEFT & RIGHT
Conformis, Inc.
RCR020000C04
In Commercial Distribution

  • M572RCR020000C041 ()
RCR-020-000C

  • Tibial insert
ITOTAL CR–IPOLY XE–LATERAL C INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000C03
In Commercial Distribution

  • M572RCR020000C031 ()

  • Thickness 8mm
RCR-020-000C

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, B, LEFT & RIGHT
Conformis, Inc.
RCR020000B14
In Commercial Distribution

  • M572RCR020000B141 ()
RCR-020-000B

  • Tibial insert
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