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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 K121297
Device Name ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
Applicant
SIGNATURE ORTHOPAEDICS, PTY, LTD
125 GREVILLE ST
CHATSWOOD,  AT 2067
Applicant Contact DECLAN BRAZIL
Correspondent
SIGNATURE ORTHOPAEDICS, PTY, LTD
125 GREVILLE ST
CHATSWOOD,  AT 2067
Correspondent Contact DECLAN BRAZIL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received04/30/2012
Decision Date 12/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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