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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 K102975
Device Name NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact VLADISLAVA ZAITSEVA
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact VLADISLAVA ZAITSEVA
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWZ   LZO  
Date Received10/06/2010
Decision Date 11/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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