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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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IDUO–TIBIAL TRAY KIT–LEFT or right MEDIAL or lateral
Conformis, Inc.
RBK101111302
In Commercial Distribution

  • M572RBK1011113021 ()

  • Patient Specific
RBK1011113

  • Bicompartmental knee prosthesis
CR JIGS, LEFT AND RIGHT
Conformis, Inc.
TCR000D00201
In Commercial Distribution

  • M572TCR000D002011 ()

  • Patient Specific
TCR-000-D002

  • Total knee prosthesis implantation guide-instrument kit
N/A
Conformis, Inc.
RUK101111302
In Commercial Distribution

  • M572RUK1011113021 ()

  • Patient Specific
RUK1011113

  • Uncoated unicondylar knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RUK101111301
Not in Commercial Distribution

  • M572RUK1011113011 ()

  • Patient Specific
RUK1011113

  • Uncoated unicondylar knee femur prosthesis
N/A
Conformis, Inc.
RUK101111203
In Commercial Distribution

  • M572RUK1011112031 ()

  • Patient Specific
RUK1011112

  • Uncoated unicondylar knee femur prosthesis
N/A
Conformis, Inc.
RUK101111202
In Commercial Distribution

  • M572RUK1011112021 ()

  • Patient Specific
RUK1011112

  • Uncoated unicondylar knee femur prosthesis
iTotal® Posterior Stabilized (PS) Knee Tibial Kit
Conformis, Inc.
RPS101111302
In Commercial Distribution

  • M572RPS1011113021 ()

  • Patient Specific
RPS1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RPS101111301
In Commercial Distribution

  • M572RPS1011113011 ()

  • Patient Specific
RPS1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
iTotal® Posterior Stabilized (PS) Knee Tibial Kit
Conformis, Inc.
RPS101111202
In Commercial Distribution

  • M572RPS1011112021 ()

  • Patient Specific
RPS1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
N/A
Conformis, Inc.
RPS101111201
In Commercial Distribution

  • M572RPS1011112011 ()

  • Patient Specific
RPS1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
ITOTAL CR IPOLY XE LATERAL K INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000K13
In Commercial Distribution

  • M572RCR020000K131 ()

  • Patient Specific
RCR020000K

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL J INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000J13
In Commercial Distribution

  • M572RCR020000J131 ()

  • Patient Specific
RCR020000J

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

  • M572RCR020000H131 ()

  • Patient Specific
RCR020000H

  • 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 CR IPOLY XE LATERAL E INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000E13
In Commercial Distribution

  • M572RCR020000E131 ()

  • Patient Specific
RCR020000E

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL D INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000D13
In Commercial Distribution

  • M572RCR020000D131 ()

  • Patient Specific
RCR020000D

  • Tibial insert
N/A
Conformis, Inc.
RCR020000C13
In Commercial Distribution

  • M572RCR020000C131 ()

  • Patient Specific
RCR020000C

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL B INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000B13
In Commercial Distribution

  • M572RCR020000B131 ()

  • Patient Specific
RCR020000B

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL A INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000A13
In Commercial Distribution

  • M572RCR020000A131 ()

  • Patient Specific
RCR020000A

  • Tibial insert
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