VENUS HIP

Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

TURNKEY INTERGRATION USA, INC.

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

Pre-market Notification Details

Device IDK913708
510k NumberK913708
Device Name:VENUS HIP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, 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 CodeLWJ  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-16
Decision Date1992-01-27

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