MicroLink All-Suture Button Fixation System (Radiopaque)

Washer, Bolt Nut

CONMED Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Microlink All-suture Button Fixation System (radiopaque).

Pre-market Notification Details

Device IDK190582
510k NumberK190582
Device Name:MicroLink All-Suture Button Fixation System (Radiopaque)
ClassificationWasher, Bolt Nut
Applicant CONMED Corporation 525 French Road Utica,  NY  13502
ContactDiana L. Nader-martone
CorrespondentDiana L. Nader-martone
CONMED Corporation 525 French Road Utica,  NY  13502
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-06
Decision Date2019-06-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30845854648906 K190582 000
30845854648890 K190582 000

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