HEALIX ADVANCE SP BIOCOMPOSITE Anchor

Fastener, Fixation, Biodegradable, 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 Sp Biocomposite Anchor.

Pre-market Notification Details

Device IDK191242
510k NumberK191242
Device Name:HEALIX ADVANCE SP BIOCOMPOSITE Anchor
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Medos International SARL Chemin-Blanc 38, Case Postale Le Locle,  CH Ch 2400
ContactElizabeth Messana
CorrespondentElizabeth Messana
DePuy Synthes Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-09
Decision Date2019-08-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705030590 K191242 000
10886705030576 K191242 000

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