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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 K243615
Device Name Physica Porous Femoral Components
Applicant
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele,  IT 33038
Applicant Contact Massimo Rosso
Correspondent
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele,  IT 33038
Correspondent Contact Massimo Rosso
Regulation Number888.3565
Classification Product Code
MBH  
Date Received11/22/2024
Decision Date 12/18/2024
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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