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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 K990481
Device Name ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
Applicant
Biodynamic Technologies, Inc.
1425 E. Newport Center Dr.
Deerfield Beach,  FL  33442
Applicant Contact DANNY HODGEMAN
Correspondent
Biodynamic Technologies, Inc.
1425 E. Newport Center Dr.
Deerfield Beach,  FL  33442
Correspondent Contact DANNY HODGEMAN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/16/1999
Decision Date 03/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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