ITotal Posterior Stabilized (PS) Knee Replacement System, ITotal Cruciate Retaining (CR) 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 Posterior Stabilized (ps) Knee Replacement System, Itotal Cruciate Retaining (cr) Knee Replacement System.

Pre-market Notification Details

Device IDK160025
510k NumberK160025
Device Name:ITotal Posterior Stabilized (PS) Knee Replacement System, ITotal Cruciate Retaining (CR) 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-06
Decision Date2016-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850268007347 K160025 000
00850268007170 K160025 000
00850268007163 K160025 000
00850268007156 K160025 000
00850268007149 K160025 000
00850268007132 K160025 000
00850268007125 K160025 000
00850268007118 K160025 000
00850268007101 K160025 000
00850268007095 K160025 000
00850268007088 K160025 000
M572RPS1011113021 K160025 000
M572RPS1011112021 K160025 000
M572TPS1111111021 K160025 000
M572RPS0102000021 K160025 000
00850268007187 K160025 000
00850268007194 K160025 000
00850268007330 K160025 000
00850268007323 K160025 000
00850268007316 K160025 000
00850268007309 K160025 000
00850268007293 K160025 000
00850268007286 K160025 000
00850268007279 K160025 000
00850268007262 K160025 000
00850268007255 K160025 000
00850268007248 K160025 000
00850268007231 K160025 000
00850268007224 K160025 000
00850268007217 K160025 000
00850268007200 K160025 000
M572RPS0101700021 K160025 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.