Acumed Clavicle Hook Plating System

Plate, Fixation, Bone

Acumed LLC

The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Clavicle Hook Plating System.

Pre-market Notification Details

Device IDK210750
510k NumberK210750
Device Name:Acumed Clavicle Hook Plating System
ClassificationPlate, Fixation, Bone
Applicant Acumed LLC 5885 NE Cornelius Pass Road Hillsboro,  OR  97124
ContactJanki Bhatt
CorrespondentJanki Bhatt
Acumed LLC 5885 NE Cornelius Pass Road Hillsboro,  OR  97124
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-12
Decision Date2021-07-15

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