ARTOS, DIPLOS SYSTEM

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

TURNKEY INTERGRATION USA, INC.

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

Pre-market Notification Details

Device IDK970284
510k NumberK970284
Device Name:ARTOS, DIPLOS SYSTEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant TURNKEY INTERGRATION USA, INC. 962 S. TAMIAMI TRAIL SUITE 203 Sarasota,  FL  34326
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-24
Decision Date1997-04-21

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