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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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N/A
Conformis, Inc.
RPS020220002
In Commercial Distribution

  • M572RPS0202200021 ()

  • 22mm thick on the medial side, lateral side is patient specific
RPS0202200

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
ITOTAL PS IPOLY XE - 21MM INSERT – LEFT or right
Conformis, Inc.
RPS020210002
In Commercial Distribution

  • M572RPS0202100021 ()

  • 21mm thick on the medial side, lateral side is patient specific
RPS-020-2100

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
N/A
Conformis, Inc.
RPS020200002
In Commercial Distribution

  • M572RPS0202000021 ()

  • 20mm thick on the medial side, lateral side is patient specific
RPS0202000

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
ITOTAL PS – IPOLY XE - 19MM INSERT - LEFT or right
Conformis, Inc.
RPS020190002
In Commercial Distribution

  • M572RPS0201900021 ()

  • 19mm thick on the medial side, lateral side is patient specific
RPS0201900

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
N/A
Conformis, Inc.
RPS020180002
In Commercial Distribution

  • M572RPS0201800021 ()

  • 18mm thick on the medial side, lateral side is patient specific
RPS0201800

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
N/A
Conformis, Inc.
RPS020170002
In Commercial Distribution

  • M572RPS0201700021 ()

  • 17mm thick on the medial side, lateral side is patient specific
RPS0201700

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
NA
Conformis, Inc.
RPS020160002
In Commercial Distribution

  • M572RPS0201600021 ()

  • 16mm thick on the medial side, lateral side is patient specific
RPS0201600

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
NA
Conformis, Inc.
RPS020150002
In Commercial Distribution

  • M572RPS0201500021 ()

  • 15mm thick on the medial side, lateral side is patient specific
RPS0201500

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
NA
Conformis, Inc.
RPS020140002
In Commercial Distribution

  • M572RPS0201400021 ()

  • 14mm thick on the medial side, lateral side is patient specific
RPS0201400

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
NA
Conformis, Inc.
RPS020130002
In Commercial Distribution

  • M572RPS0201300021 ()

  • 13mm thick on the medial side, lateral side is patient specific
RPS0201300

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
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