ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM

Plate, Fixation, Bone

ACUMED LLC

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

Pre-market Notification Details

Device IDK051083
510k NumberK051083
Device Name:ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro,  OR  97124 -9432
ContactEd Boehmer
CorrespondentEd Boehmer
ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro,  OR  97124 -9432
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-27
Decision Date2005-05-12
Summary:summary

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