ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR

Washer, Bolt Nut

ACUMED LLC

The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acu-sinch Repair System And Acumed Suture Anchor.

Pre-market Notification Details

Device IDK112111
510k NumberK112111
Device Name:ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
ClassificationWasher, Bolt Nut
Applicant ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro,  OR  97124 -9432
ContactLino Tsai
CorrespondentLino Tsai
ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro,  OR  97124 -9432
Product CodeHTN  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
Subsequent Product CodeMBI
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-25
Decision Date2011-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10806378095085 K112111 000
10806378095078 K112111 000
10806378092909 K112111 000
10806378091001 K112111 000
10806378090998 K112111 000
10806378045349 K112111 000
10806378029547 K112111 000
10806378034879 K112111 000

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