MasterLoc Stem

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Masterloc Stem.

Pre-market Notification Details

Device IDK160289
510k NumberK160289
Device Name:MasterLoc Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant MEDACTA INTERNATIONAL STRADA REGINA Castel San Pietro,  CH Ch 6874
ContactMichael G. Loiterman
CorrespondentRoshana Ahmed
Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington,  KY  40504
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeLPH
Subsequent Product CodeLZY
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-03
Decision Date2016-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030885631 K160289 000
07630030885624 K160289 000
07630030885525 K160289 000
07630030885518 K160289 000
07630030861284 K160289 000
07630030861260 K160289 000

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