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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 K964262
Device Name EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
Applicant
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Applicant Contact MARTHA MILLER
Correspondent
Exactech, Inc.
4613 NW 6th St., Suite D
Gainesville,  FL  32609
Correspondent Contact MARTHA MILLER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received10/25/1996
Decision Date 12/27/1996
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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