CuffLink Implant System Biocomposite

Fastener, Fixation, Biodegradable, Soft Tissue

CONMED Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Cufflink Implant System Biocomposite.

Pre-market Notification Details

Device IDK180763
510k NumberK180763
Device Name:CuffLink Implant System Biocomposite
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
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 CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-23
Decision Date2018-07-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10845854046098 K180763 000
10845854046081 K180763 000
10845854046074 K180763 000
10845854046067 K180763 000
10845854046111 K180763 000
10845854046104 K180763 000

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