ARTHREX UNIVERS APEX

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

ARTHREX, INC.

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

Pre-market Notification Details

Device IDK131633
510k NumberK131633
Device Name:ARTHREX UNIVERS APEX
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactCourtney Smith
CorrespondentCourtney Smith
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-04
Decision Date2013-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888867213524 K131633 000
00888867134454 K131633 000
00888867134508 K131633 000
00888867134553 K131633 000
00888867134607 K131633 000
00888867134652 K131633 000
00888867134706 K131633 000
00888867134751 K131633 000
00888867134799 K131633 000
00888867134836 K131633 000
00888867134416 K131633 000

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