ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

CONFORMIS, INC.

The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Cruciate Retaining (cr) Knee Replacement System, Itotal Posterior Stabilized (ps) Knee Replacement System.

Pre-market Notification Details

Device IDK142161
510k NumberK142161
Device Name:ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant CONFORMIS, INC. 28 Crosby Dr Bedford,  MA  01730
ContactAmita Shah
CorrespondentAmita Shah
CONFORMIS, INC. 28 Crosby Dr Bedford,  MA  01730
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-06
Decision Date2014-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M572RPS1011113011 K142161 000
M572RPS0101100011 K142161 000
M572PAT0113206011 K142161 000
M572PAT0113507011 K142161 000
M572PAT0113808011 K142161 000
M572PAT0114110011 K142161 000
M572PAT0212906011 K142161 000
M572PAT0213206011 K142161 000
M572PAT0213507011 K142161 000
M572PAT0213808011 K142161 000
M572PAT0214110011 K142161 000
M572PAT0112906011 K142161 000
M572RPS1011112011 K142161 000
M572RPS0101000011 K142161 000

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