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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 K200653
Device Name AMF Revision TT Cones
Applicant
LimaCorporate S.p.A
Via Nazionale 52
Villanova di San Daniele del Friuli,  IT 33038
Applicant Contact Roberto Gabetta
Correspondent
Lima USA Inc
2001 NE Green Oaks Blvd. Ste.100
Arlington,  TX  76006
Correspondent Contact Lacey Harbour
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received03/12/2020
Decision Date 05/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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