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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 K032300
Device Name ACCOLADE-J HIP STEM SERIES
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
allendale,  NJ  07401 -1677
Applicant Contact lorraine montemurro
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
allendale,  NJ  07401 -1677
Correspondent Contact lorraine montemurro
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LZO  
Date Received07/25/2003
Decision Date 10/09/2003
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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