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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K172456
Device Name Bone Screws 6.5mm
Applicant
Lima Corporate S.P.A.
Via Nazionale, 52
33038 Villanova Di San Daniele
Udine,  IT
Applicant Contact Michela Zanotto
Correspondent
Lima Corporate S.P.A.
Via Nazionale, 52
33038 Villanova Di San Daniele
Udine,  IT
Correspondent Contact Stephen J. Peoples
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MBF   MBL   PHX  
Date Received08/14/2017
Decision Date 01/04/2018
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
Recalls CDRH Recalls
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