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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 K070885
Device Name UNIVERSAL TAPER DELTA FEMORAL HEAD
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact TIFFANI ROGERS
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3353
Classification Product Code
LZO  
Date Received03/30/2007
Decision Date 05/16/2007
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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