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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K994366
Device Name TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
Applicant
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
rutherford,  NJ  07070 -2584
Applicant Contact nancy j rieder
Correspondent
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
rutherford,  NJ  07070 -2584
Correspondent Contact nancy j rieder
Regulation Number888.3353
Classification Product Code
MEH  
Date Received12/27/1999
Decision Date 03/16/2000
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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