CuffLink Implant System

Fastener, Fixation, Nondegradable, Soft Tissue

CONMED Corporation

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

Pre-market Notification Details

Device IDK171725
510k NumberK171725
Device Name:CuffLink Implant System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant CONMED Corporation 525 French Road Utica,  NY  13502
ContactDionne Sanders
CorrespondentDionne Sanders
CONMED Corporation 525 French Road Utica,  NY  13502
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-12
Decision Date2017-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10845854045213 K171725 000
10845854045206 K171725 000
10845854045190 K171725 000
10845854045183 K171725 000
10845854045176 K171725 000
10845854045169 K171725 000

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