FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)

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 32mm).

Pre-market Notification Details

Device IDK910548
510k NumberK910548
Device Name:FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)
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
ContactD. W Stuart
CorrespondentD. 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 Date1991-04-09

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