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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 K201084
Device Name Physica system
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
San Daniele Del Friuli,  IT 33038
Applicant Contact Michela Zanotto
Correspondent
Peoples & Associates Consulting, LLC
5010 Lodge Pole Lane
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
HRY   JWH  
Date Received04/23/2020
Decision Date 12/14/2020
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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