ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM

Screw, Fixation, Bone

ACUMED LLC

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

Pre-market Notification Details

Device IDK033639
510k NumberK033639
Device Name:ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
ClassificationScrew, 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 CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-20
Decision Date2004-01-15
Summary:summary

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