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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 K112898
Device Name DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
Applicant
LIMACORPORATE S.P.A.
p.o. box 696
winona lake,  IN  46590 696
Contact cheryl hastings
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MBL  
Date Received10/03/2011
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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