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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K141934
Device Name PHYSICA KR KNEE SYSTEM
Applicant
Lima Corporate S.P.A.
Via Nazionale, 52
Villanova Di San Daniele Udine,  IT
Applicant Contact EMANUELE BUTTAZZONI
Correspondent
Lima Corporate S.P.A.
5010 Lodge Pole Lane
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
HRY  
Date Received07/17/2014
Decision Date 04/02/2015
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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