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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 TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, K, LEFT & RIGHT
Conformis, Inc.
RCR020000K14
In Commercial Distribution

  • M572RCR020000K141 ()
RCR-020-000K

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL K INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000K13
In Commercial Distribution

  • M572RCR020000K131 ()

  • Patient Specific
RCR020000K

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, LATERAL, K, LEFT & RIGHT
Conformis, Inc.
RCR020000K04
In Commercial Distribution

  • M572RCR020000K041 ()
RCR-020-000K

  • Tibial insert
ITOTAL CR–IPOLY XE–LATERAL K INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000K03
In Commercial Distribution

  • M572RCR020000K031 ()

  • Thickness 16mm
RCR-020-000K

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, J, LEFT & RIGHT
Conformis, Inc.
RCR020000J14
In Commercial Distribution

  • M572RCR020000J141 ()
RCR-020-000J

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL J INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000J13
In Commercial Distribution

  • M572RCR020000J131 ()

  • Patient Specific
RCR020000J

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, LATERAL, J, LEFT & RIGHT
Conformis, Inc.
RCR020000J04
In Commercial Distribution

  • M572RCR020000J041 ()
RCR-020-000J

  • Tibial insert
ITOTAL CR–IPOLY XE–LATERAL J INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000J03
In Commercial Distribution

  • M572RCR020000J031 ()

  • Thickness 15mm
RCR-020-000J

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL I INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000I13
In Commercial Distribution

  • M572RCR020000I131 ()

  • Patient Specific
RCR020000I

  • Tibial insert
ITOTAL CR–IPOLY XE–LATERAL I INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000I03
In Commercial Distribution

  • M572RCR020000I031 ()

  • thickness 14 mm
RCR-020-000I

  • Tibial insert
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