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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 K901297
Device Name EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP
Applicant
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
gainesville,  FL  32609
Applicant Contact william petty
Correspondent
EXACTECH, INC.
4613 N.W. 6TH STREET, SUITE D
gainesville,  FL  32609
Correspondent Contact william petty
Regulation Number888.3350
Classification Product Code
JDI  
Date Received03/20/1990
Decision Date 05/02/1990
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
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