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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 K990596
Device Name DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
Applicant
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO,  CA  92121
Applicant Contact LOUISE M FOCHT
Correspondent
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO,  CA  92121
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/24/1999
Decision Date 04/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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