MOVATION KNEE SYSTEM

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

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Movation Knee System.

Pre-market Notification Details

Device IDK121727
510k NumberK121727
Device Name:MOVATION KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
Applicant ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
ContactWilliam Garzon
CorrespondentWilliam Garzon
ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeOIY  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-12
Decision Date2012-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888912113267 K121727 000
00888912112802 K121727 000
00888912112796 K121727 000
00888912112772 K121727 000
00888912112758 K121727 000
00888912112734 K121727 000
00888912112642 K121727 000
00888912112635 K121727 000
00888912112628 K121727 000
00888912112598 K121727 000
00888912112574 K121727 000
00888912112550 K121727 000
00888912112451 K121727 000
00888912112444 K121727 000
00888912112437 K121727 000
00888912112413 K121727 000
00888912112390 K121727 000
00888912112819 K121727 000
00888912112901 K121727 000
00888912113250 K121727 000
00888912113243 K121727 000
00888912113229 K121727 000
00888912113205 K121727 000
00888912113182 K121727 000
00888912113151 K121727 000
00888912113144 K121727 000
00888912113137 K121727 000
00888912113113 K121727 000
00888912113090 K121727 000
00888912113076 K121727 000
00888912112987 K121727 000
00888912112970 K121727 000
00888912112963 K121727 000
00888912112949 K121727 000
00888912112925 K121727 000
00888912112376 K121727 000

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