CERCLAGE WIRE CRIMP SLEEVE

Cerclage, Fixation

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Cerclage Wire Crimp Sleeve.

Pre-market Notification Details

Device IDK931246
510k NumberK931246
Device Name:CERCLAGE WIRE CRIMP SLEEVE
ClassificationCerclage, Fixation
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-11
Decision Date1994-02-22

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