LINK SADDLE PROTHESIS

Prosthesis, Hip, Hemi-, Femoral, Metal

TURNKEY INTERGRATION USA, INC.

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

Pre-market Notification Details

Device IDK951355
510k NumberK951355
Device Name:LINK SADDLE PROTHESIS
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis,  IN  46250 -1290
ContactDouglas W Stuart
CorrespondentDouglas W Stuart
TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis,  IN  46250 -1290
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-08
Decision Date1995-05-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04026575047840 K951355 000
04026575047765 K951355 000

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