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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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Hero 2 & IS Dental Implant System/Fixture
KJMEDITECH.CO.,LTD
MAF400130
In Commercial Distribution

  • 08809488216734 ()


  • Screw endosteal dental implant, two-piece
Hero 2 & IS Dental Implant System/Fixture
KJMEDITECH.CO.,LTD
MAF400085
In Commercial Distribution

  • 08809488216703 ()


  • Screw endosteal dental implant, two-piece
Hero 2 & IS Dental Implant System/Fixture
KJMEDITECH.CO.,LTD
MAF375130
In Commercial Distribution

  • 08809488216680 ()


  • Screw endosteal dental implant, two-piece
Hero 2 & IS Dental Implant System/Fixture
KJMEDITECH.CO.,LTD
MAF375100
In Commercial Distribution

  • 08809488216666 ()


  • Screw endosteal dental implant, two-piece
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
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