CrossFT Knotless Suture Anchor With Disposable Driver

Fastener, Fixation, Nondegradable, Soft Tissue

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Crossft Knotless Suture Anchor With Disposable Driver.

Pre-market Notification Details

Device IDK163258
510k NumberK163258
Device Name:CrossFT Knotless Suture Anchor With Disposable Driver
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ConMed Corporation 525 French Road Utica,  NY  13502
ContactNyrobia Freeman
CorrespondentNyrobia Freeman
ConMed Corporation 525 French Road Utica,  NY  13502
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-21
Decision Date2017-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854649838 K163258 000
20845854649821 K163258 000
10845854044599 K163258 000

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