FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)

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

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Feldmuehle Ceramic Head (12/14 X 28mm).

Pre-market Notification Details

Device IDK910547
510k NumberK910547
Device Name:FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-07
Decision Date1991-04-12

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