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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 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
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, H, LEFT & RIGHT
Conformis, Inc.
RCR020000H14
In Commercial Distribution

  • M572RCR020000H141 ()
RCR-020-000H

  • Tibial insert
N/A
Conformis, Inc.
RCR020000H13
Not in Commercial Distribution

  • M572RCR020000H131 ()

  • Patient Specific
RCR020000H

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, LATERAL, H, LEFT & RIGHT
Conformis, Inc.
RCR020000H04
In Commercial Distribution

  • M572RCR020000H041 ()
RCR-020-000H

  • Tibial insert
ITOTAL CR–IPOLY XE–LATERAL H INSERT KIT–LEFT or right
Conformis, Inc.
RCR-020-000H03
In Commercial Distribution

  • M572RCR020000H031 ()

  • Thickness 13mm
RCR-020-000H

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, G, LEFT & RIGHT
Conformis, Inc.
RCR020000G14
In Commercial Distribution

  • M572RCR020000G141 ()
RCR-020-000G

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL G INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000G13
In Commercial Distribution

  • M572RCR020000G131 ()

  • Patient Specific
RCR020000G

  • Tibial insert
ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY XE, LATERAL, G, LEFT & RIGHT
Conformis, Inc.
RCR020000G04
In Commercial Distribution

  • M572RCR020000G041 ()
RCR-020-000G

  • Tibial insert
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