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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(K) Number K961497
Device Name PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
Applicant
HOWMEDICA, INC.
359 veterans blvd.
rutherford,  NJ  07070 2584
Contact john dichiara
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/18/1996
Decision Date 06/28/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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