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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 K153131
Device Name Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
Applicant
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Applicant Contact DECLAN BRAZIL
Correspondent
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Correspondent Contact DECLAN BRAZIL
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWZ   LPH  
Date Received10/30/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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