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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K250980
Device Name Physica System (Physica CR Porous Femoral components)
Applicant
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele,  IT 33038
Applicant Contact Simone De Marco
Correspondent
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele,  IT 33038
Correspondent Contact Simone De Marco
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
HRY   JWH  
Date Received03/31/2025
Decision Date 05/22/2025
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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