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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 PS IPOLY XE - 13MM INSERT - LEFT or right NO TRIAL
Conformis, Inc.
RPS-020-130012
In Commercial Distribution

  • M572RPS0201300121 ()

  • Thickness 13mm
RPS-020-1300

  • Tibial insert
iTOTAL PS IPOLY XE - 12MM INSERT - LEFT or right NO TRIAL
Conformis, Inc.
RPS-020-120012
In Commercial Distribution

  • M572RPS0201200121 ()

  • Thickness 12mm
RPS-020-1200

  • Tibial insert
ITOTAL PS / IPOLY XE - 11MM INSERT - LEFT or right NO TRIAL
Conformis, Inc.
RPS-020-110012
In Commercial Distribution

  • M572RPS0201100121 ()

  • Thickness 11mm
RPS-020-1100

  • Tibial insert
ITOTAL PS IPOLY XE - 10MM INSERT - LEFT or right NO TRIAL
Conformis, Inc.
RPS-020-100012
In Commercial Distribution

  • M572RPS0201000121 ()

  • Thickness 10mm
RPS-020-1000

  • Tibial insert
ITOTAL PS IPOLY XE - 9MM INSERT - RIGHT NO TRIAL
Conformis, Inc.
RPS-020-090012
In Commercial Distribution

  • M572RPS0200900121 ()

  • Thickness 9mm
RPS-020-0900

  • Tibial insert
ITOTAL PS/ IPOLY XE - 8MM INSERT - RIGHT or left NO TRIAL
Conformis, Inc.
RPS-020-080012
In Commercial Distribution

  • M572RPS0200800121 ()

  • Thickness 8mm
RPS-020-0800

  • Tibial insert
ITOTAL PS IPOLY XE - 7MM INSERT - RIGHT or left NO TRIAL
Conformis, Inc.
RPS-020-070012
In Commercial Distribution

  • M572RPS0200700121 ()

  • Thickness 7mm
RPS-020-0700

  • Tibial insert
ITOTAL PS IPOLY XE - 6MM INSERT - LEFT or right NO TRIAL
Conformis, Inc.
RPS-020-060012
In Commercial Distribution

  • M572RPS0200600121 ()

  • Thickness 6mm
RPS-020-0600

  • Tibial insert
ITOTAL PS IPOLY 22MM INSERT LEFT or right
Conformis, Inc.
RPS-010-220002
In Commercial Distribution

  • M572RPS0102200021 ()

  • Thickness 22mm
RPS-010-2200

  • Tibial insert
ITOTAL PS - IPOLY - 20MM INSERT - LEFT or right NO TRIAL
Conformis, Inc.
RPS-010-200012
In Commercial Distribution

  • M572RPS0102000121 ()

  • Thickness 20mm
RPS-010-2000

  • Tibial insert
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