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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K252352
Device Name SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
Applicant
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele,  IT 33038
Applicant Contact Lilia Maestripieri
Correspondent
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele,  IT 33038
Correspondent Contact Lilia Maestripieri
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
MBF  
Date Received07/29/2025
Decision Date 01/22/2026
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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