CONGRUENT 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 Congruent Bone Plate System.

Pre-market Notification Details

Device IDK012655
510k NumberK012655
Device Name:CONGRUENT 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 Received2001-08-13
Decision Date2001-11-07
Summary:summary

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