ARTHREX ARTHROSCOPE

Arthroscope

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Arthroscope.

Pre-market Notification Details

Device IDK921119
510k NumberK921119
Device Name:ARTHREX ARTHROSCOPE
ClassificationArthroscope
Applicant ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples,  FL  33942
ContactDon Grafton
CorrespondentDon Grafton
ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples,  FL  33942
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-09
Decision Date1994-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888867100497 K921119 000
00888867028951 K921119 000

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