MicroLink All-Suture Button Fixation System (Radiolucent)

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 (radiolucent).

Pre-market Notification Details

Device IDK190516
510k NumberK190516
Device Name:MicroLink All-Suture Button Fixation System (Radiolucent)
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 Received2019-03-04
Decision Date2019-06-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30845854648876 K190516 000
30845854648869 K190516 000
40845854648873 K190516 000
40845854648866 K190516 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.