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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 K003923
Device Name APEX MODULAR ZIRCONIA FEMORAL HEAD
Applicant
Apex Surgical, LLC
12 Harding St.,Suite 202
Lakeville,  MA  02347
Applicant Contact EDWARD J CHEAL
Correspondent
Apex Surgical, LLC
12 Harding St.,Suite 202
Lakeville,  MA  02347
Correspondent Contact EDWARD J CHEAL
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/20/2000
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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