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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, Femoral Component, Cemented, Metal
510(k) Number K915391
Device Name FPC HIP STEM COMPONENT
Applicant
Implantology Corp.
11 Oak Ln.
Pine Brook,  NJ  07058
Applicant Contact MARK FORTE
Correspondent
Implantology Corp.
11 Oak Ln.
Pine Brook,  NJ  07058
Correspondent Contact MARK FORTE
Regulation Number888.3360
Classification Product Code
JDG  
Date Received11/29/1991
Decision Date 04/30/1993
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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