BONE ANCHOR

Staple, Fixation, Bone

ACUMED, INC.

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

Pre-market Notification Details

Device IDK942787
510k NumberK942787
Device Name:BONE ANCHOR
ClassificationStaple, Fixation, Bone
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactShari L Jeffers
CorrespondentShari L Jeffers
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-13
Decision Date1994-12-15

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