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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 K081679
Device Name REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05
Applicant
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact TEFFANY HUTTO
Correspondent
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact TEFFANY HUTTO
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWZ   LZO  
Date Received06/17/2008
Decision Date 08/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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