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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 K000788
Device Name APEX MODULAR HIP STEM
Applicant
Apex Surgical, LLC
39 Taunton Green, Suite 202
Taunton,  MA  02780
Applicant Contact EDWARD J CHEAL
Correspondent
Apex Surgical, LLC
39 Taunton Green, Suite 202
Taunton,  MA  02780
Correspondent Contact EDWARD J CHEAL
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/10/2000
Decision Date 08/04/2000
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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