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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 K965002
Device Name ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
Applicant
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Applicant Contact ASHLEY M BOCK
Correspondent
Encore Orthopedics, Inc.
8900 Shoal Creek Blvd.,
Bldg. 300
Austin,  TX  78757
Correspondent Contact ASHLEY M BOCK
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/16/1996
Decision Date 06/27/1997
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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