FDA 510(k) Application Details - K962987

Device Classification Name Screw, Fixation, Bone

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510(K) Number K962987
Device Name Screw, Fixation, Bone
Applicant BIODYNAMIC TECHNOLOGIES, INC.
1425 EAST NEWPORT CENTER DR.
DEERFIELD BEACH, FL 33442 US
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Contact DANNY HODGEMAN
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 08/01/1996
Decision Date 11/04/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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