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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, Uncemented
510(k) Number K223876
Device Name SMR Shoulder System
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Francesca Marello
Correspondent
Lima U.S.A., Inc.
2001 NE Green Oaks Blvd.
Suite 100
Arlington,  TX  76006
Correspondent Contact Kenneth Newman
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
KWS   KWT   PAO   PHX  
Date Received12/23/2022
Decision Date 02/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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