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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 K062489
Device Name APEX HCLA ACETABULAR CUP LINERS
Applicant
Omnilife Science
175 Paramount Dr.
Suite 302
Raynham,  MA  02767
Applicant Contact EDWARD CHEAL
Correspondent
Omnilife Science
175 Paramount Dr.
Suite 302
Raynham,  MA  02767
Correspondent Contact EDWARD CHEAL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MEH  
Date Received08/25/2006
Decision Date 08/15/2007
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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