Acumed Ankle Syndesmosis Repair System

Washer, Bolt Nut

Acumed LLC

The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Ankle Syndesmosis Repair System.

Pre-market Notification Details

Device IDK212990
510k NumberK212990
Device Name:Acumed Ankle Syndesmosis Repair System
ClassificationWasher, Bolt Nut
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 CodeHTN  
Subsequent Product CodeHTW
Subsequent Product CodeLXH
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2022-01-07

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