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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 K963313
Device Name EXACTECH ALL POLY ACETABULAR CUP
Applicant
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Applicant Contact MARTHA MILLER
Correspondent
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
GAINESVILLE,  FL  32609
Correspondent Contact MARTHA MILLER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received08/22/1996
Decision Date 11/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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