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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, Cemented
510(k) Number K925201
Device Name EXACTECH FEMORAL STEM
Applicant
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Applicant Contact TIMOTHY J SEESE
Correspondent
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Correspondent Contact TIMOTHY J SEESE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received10/16/1992
Decision Date 06/15/1993
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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