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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 K862234
Device Name EXACTECH TOTAL HIP SYSTEM
Applicant
Exactech, Inc.
2210 NW 28th St.
Gainesville,  FL  32605
Applicant Contact WILLIAM PETTY
Correspondent
Exactech, Inc.
2210 NW 28th St.
Gainesville,  FL  32605
Correspondent Contact WILLIAM PETTY
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/11/1986
Decision Date 10/15/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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