HEALIX ADVANCE Anchor With DYNA+TAPE Sutures

Fastener, Fixation, Nondegradable, Soft Tissue

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Anchor With Dyna+tape Sutures.

Pre-market Notification Details

Device IDK191483
510k NumberK191483
Device Name:HEALIX ADVANCE Anchor With DYNA+TAPE Sutures
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Medos International SARL Chemin-Blanc 38, Case Postale Le Locle,  CH Ch 2400
ContactAshley Goncalo
CorrespondentAshley Goncalo
DePuy Synthes Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2019-06-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705030941 K191483 000
10886705030842 K191483 000
10886705030859 K191483 000
10886705030866 K191483 000
10886705030873 K191483 000
10886705030880 K191483 000
10886705030897 K191483 000
10886705030903 K191483 000
10886705030910 K191483 000
10886705030927 K191483 000
10886705030934 K191483 000
10886705030835 K191483 000

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