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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K231925
Device Name MINIMA S System
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
San Daniele Del Friuli,  IT 33038
Applicant Contact Kenneth Newman
Correspondent
Lima Corporate S.P.A.
Via Nazionale 52
San Daniele Del Friuli,  IT 33038
Correspondent Contact Kenneth Newman
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWY   KWZ   LPH   MBL  
Date Received06/30/2023
Decision Date 07/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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