CrossFT Knotless Deep Thread 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 Deep Thread Suture Anchor With Disposable Driver.

Pre-market Notification Details

Device IDK182621
510k NumberK182621
Device Name:CrossFT Knotless Deep Thread Suture Anchor With Disposable Driver
ClassificationFastener, Fixation, Nondegradable, 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 CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-24
Decision Date2019-01-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10845854606315 K182621 000
10845854606230 K182621 000

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