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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 K210554
Device Name Physica system
Applicant
Lima Corporate S.P.A.
Via Nazionale, 52 Villanova Di San Daniele
Udine,  IT 33038
Applicant Contact Giuseppe Valenti
Correspondent
Lima U.S.A., Inc.
2001 NE Green Oaks Blvd. Suite 100
Arlington,  TX  76006
Correspondent Contact Lacey Harbour
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
HRY   JWH  
Date Received02/25/2021
Decision Date 04/06/2021
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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