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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K160289
Device Name MasterLoc Stem
Applicant
MEDACTA INTERNATIONAL
STRADA REGINA
CASTEL SAN PIETRO,  CH CH 6874
Applicant Contact MICHAEL G. LOITERMAN
Correspondent
Mapi USA, Inc.
2343 Alexandria Drive, Suite 100
Lexington,  KY  40504
Correspondent Contact Roshana Ahmed
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LPH   LZY   MEH  
Date Received02/03/2016
Decision Date 05/20/2016
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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