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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder arthroplasty implantation system
510(k) Number K222007
Device Name Arthrex Virtual Implant Positioning (VIP) System
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108
Applicant Contact Ivette Galmez
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108
Correspondent Contact Ivette Galmez
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   LLZ   PHX  
Date Received07/07/2022
Decision Date 03/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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