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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K172210
Device Name ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Applicant
Stryker Trauma AG
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Tina Mornak
Correspondent
Stryker Trauma AG
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Tina Mornak
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   PHX  
Date Received07/24/2017
Decision Date 10/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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