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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 K041461
Device Name KMI DISTAL VOLAR RADIUS PLATE SYSTEM
Applicant
KINETIKOS MEDICAL, INC.
6005 hidden valley rd, ste 180
carlsbad,  CA  92011
Contact john g spampinato
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/02/2004
Decision Date 08/16/2004
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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