ACUTRACT

Screw, Fixation, Bone

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acutract.

Pre-market Notification Details

Device IDK930834
510k NumberK930834
Device Name:ACUTRACT
ClassificationScrew, Fixation, Bone
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactGene Conrad
CorrespondentGene Conrad
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-17
Decision Date1993-07-26

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