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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K150855
Device Name H-MAX S Femoral Hip System
Applicant
Limacorporate S.P.A.
Via Nazionale, 52
Villanova di San Daniele,  IT 33038
Applicant Contact Sara Viel
Correspondent
Limacorporate S.P.A.
Via Nazionale, 52
Villanova di San Daniele,  IT 33038
Correspondent Contact Stephen J Peoples
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
JDI   KWY   LPH  
Date Received03/31/2015
Decision Date 10/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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