OMNI-FIX, NAIL SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Single Component

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Omni-fix, Nail System.

Pre-market Notification Details

Device IDK990307
510k NumberK990307
Device Name:OMNI-FIX, NAIL SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Single Component
Applicant TURNKEY INTERGRATION USA, INC. 962 SOUTH TAMIAMI TRAIL, SUITE 203 Sarasota,  FL  34326
ContactDouglas W Stewart
CorrespondentDouglas W Stewart
TURNKEY INTERGRATION USA, INC. 962 SOUTH TAMIAMI TRAIL, SUITE 203 Sarasota,  FL  34326
Product CodeKTW  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-01
Decision Date1999-04-01

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