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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 PS TIBIAL INSERT + TRIAL, IPOLY, 18MM
Conformis, Inc.
RPS010180003
In Commercial Distribution

  • M572RPS0101800031 ()

  • Height: 18 Millimeter
RPS-010-1800

  • Tibial insert
iTotalĀ® Posterior Stabilized (PS) Knee Insert Kit
Conformis, Inc.
RPS010180002
In Commercial Distribution

  • M572RPS0101800021 ()

  • 18mm thick on the medial side, lateral side is patient specific
RPS0101800

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
ITOTAL PS - IPOLY - 18MM INSERT - LEFT or right
Conformis, Inc.
RPS-010-180001
In Commercial Distribution

  • M572RPS0101800011 ()

  • Thickness 18mm
RPS-010-1800

  • Tibial insert
ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 17MM
Conformis, Inc.
RPS010170013
In Commercial Distribution

  • M572RPS0101700131 ()

  • Height: 17 Millimeter
RPS0101700

  • Tibial insert
ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY, 17MM
Conformis, Inc.
RPS010170003
In Commercial Distribution

  • M572RPS0101700031 ()

  • Height: 17 Millimeter
RPS-010-1700

  • Tibial insert
PS TIBIAL TRAY SIZE 7
Conformis, Inc.
TPS301T07S01
In Commercial Distribution

  • M572TPS301T07S011 ()

  • tibial tray size 7
TPS-301-T07S

  • Uncoated knee tibia prosthesis, metallic
PS TIBIAL TRAY SIZE 6
Conformis, Inc.
TPS301T06S01
In Commercial Distribution

  • M572TPS301T06S011 ()

  • tibial tray size 6
TPS-301-T06S

  • Uncoated knee tibia prosthesis, metallic
PS TIBIAL TRAY SIZE 6 NARROW
Conformis, Inc.
TPS301T06N01
In Commercial Distribution

  • M572TPS301T06N011 ()

  • tibial tray size 6 narrow
TPS-301-T06N

  • Uncoated knee tibia prosthesis, metallic
PS TIBIAL TRAY SIZE 5
Conformis, Inc.
TPS301T05S01
In Commercial Distribution

  • M572TPS301T05S011 ()

  • tibial tray size 5
TPS-301-T05S

  • Uncoated knee tibia prosthesis, metallic
PS TIBIAL TRAY SIZE 5 NARROW
Conformis, Inc.
TPS301T05N01
In Commercial Distribution

  • M572TPS301T05N011 ()

  • tibial tray size 5 narrow
TPS-301-T05N

  • Uncoated knee tibia prosthesis, metallic
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