ACUMED WRIST SPANNING PLATE

Plate, Fixation, Bone

ACUMED LLC

The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Wrist Spanning Plate.

Pre-market Notification Details

Device IDK131764
510k NumberK131764
Device Name:ACUMED WRIST SPANNING PLATE
ClassificationPlate, Fixation, Bone
Applicant ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro,  OR  97124
ContactNathan Wolf
CorrespondentNathan Wolf
ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro,  OR  97124
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-17
Decision Date2013-09-05
Summary:summary

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