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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 K981715
Device Name DISTAL RADIUS FRACTURE FIXATION PLATE
Original Applicant
AVANTA ORTHOPAEDICS, INC.
9369 carroll park drive, ste.a
san diego,  CA  92121
Original Contact louise m focht
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/15/1998
Decision Date 07/29/1998
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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