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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 K921114
Device Name EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
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 Number888.3358
Classification Product Code
LPH  
Date Received03/09/1992
Decision Date 10/27/1993
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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