BONE PLATE SYSTEM

Plate, Fixation, Bone

ACUMED, INC.

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

Pre-market Notification Details

Device IDK942359
510k NumberK942359
Device Name:BONE PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactShari Jeffers
CorrespondentShari Jeffers
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-17
Decision Date1995-04-13

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