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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 K182099
Device Name Delta TT Pro
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
San Daniele Del Friuli,  IT 33038
Applicant Contact Roberto Gabetta
Correspondent
Lima Corporate S.P.A.
Via Nazionale 52
San Daniele Del Friuli,  IT 33038
Correspondent Contact Roberto Gabetta
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MBL  
Date Received08/03/2018
Decision Date 12/26/2018
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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