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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 K133370
Device Name REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
Applicant
Signature Orthopaedics Pty Limited
7 Sirius Rd.
Lane Cove
Nsw,  AU 2066
Applicant Contact DECLAN BRAZIL
Correspondent
Signature Orthopaedics Pty Limited
7 Sirius Rd.
Lane Cove
Nsw,  AU 2066
Correspondent Contact DECLAN BRAZIL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY   LZO  
Date Received11/04/2013
Decision Date 07/22/2014
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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