ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

CONMED CORPORATION

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Enhance Allograft Wedge Instrument Tray.

Pre-market Notification Details

Device IDK152969
510k NumberK152969
Device Name:ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant CONMED CORPORATION 525 FRENCH ROAD Utica,  NY  13502
ContactDionne Sanders
CorrespondentDionne Sanders
CONMED CORPORATION 525 FRENCH ROAD Utica,  NY  13502
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-08
Decision Date2016-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30845854052062 K152969 000

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