CrossFT Knotless Biocomposite Suture Anchor With Disposable Driver

Fastener, Fixation, Biodegradable, Soft Tissue

ConMed Corporation

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

Pre-market Notification Details

Device IDK170501
510k NumberK170501
Device Name:CrossFT Knotless Biocomposite Suture Anchor With Disposable Driver
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-21
Decision Date2017-03-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854045791 K170501 000
10845854045800 K170501 000
10845854045862 K170501 000
10845854045855 K170501 000
10845854045848 K170501 000
10845854045831 K170501 000
10845854045824 K170501 000
10845854045817 K170501 000
10845854045787 K170501 000

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