ACUMED SUTURE ANCHOR SYSTEM

Fastener, Fixation, Nondegradable, Soft Tissue

ACUMED, LLC

The following data is part of a premarket notification filed by Acumed, Llc with the FDA for Acumed Suture Anchor System.

Pre-market Notification Details

Device IDK133469
510k NumberK133469
Device Name:ACUMED SUTURE ANCHOR SYSTEM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ACUMED, LLC 5885 NW CORNELIUS PASS ROAD Hillsboro,  OR  97124
ContactLino Tsai
CorrespondentLino Tsai
ACUMED, LLC 5885 NW CORNELIUS PASS ROAD Hillsboro,  OR  97124
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-12
Decision Date2014-03-10
Summary:summary

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