LIMA CEMENT RESTRICTOR

Prosthesis, Hip, Cement Restrictor

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Lima Cement Restrictor.

Pre-market Notification Details

Device IDK911338
510k NumberK911338
Device Name:LIMA CEMENT RESTRICTOR
ClassificationProsthesis, Hip, Cement Restrictor
Applicant TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis,  IN  46250
ContactDouglas W Stuart
CorrespondentDouglas W Stuart
TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis,  IN  46250
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-26
Decision Date1991-06-28

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