Infinity Fixation 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 Infinity Fixation System.

Pre-market Notification Details

Device IDK191204
510k NumberK191204
Device Name:Infinity Fixation System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ConMed Corporation 525 French Road Utica,  NY  13502
ContactOrjada Dervishleri
CorrespondentOrjada Dervishleri
ConMed Corporation 525 French Road Utica,  NY  13502
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-06
Decision Date2019-07-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854901806 K191204 000
20845854901790 K191204 000
10845854901786 K191204 000
10845854901779 K191204 000
10845854901762 K191204 000
20845854649111 K191204 000
20845854649104 K191204 000
20845854649074 K191204 000
20845854649067 K191204 000

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