WRIST FUSION PLATE

Plate, Fixation, Bone

ACUMED, INC.

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

Pre-market Notification Details

Device IDK021321
510k NumberK021321
Device Name:WRIST FUSION PLATE
ClassificationPlate, Fixation, Bone
Applicant ACUMED, INC. 5885 NW CORNELIUS PASS RD. Hillsboro,  OR  97124 -9432
ContactCarrie Mcmichael
CorrespondentCarrie Mcmichael
ACUMED, INC. 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 Received2002-04-25
Decision Date2002-07-17
Summary:summary

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