FDA 510(k) Application Details - K013903

Device Classification Name Screw, Fixation, Bone

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510(K) Number K013903
Device Name Screw, Fixation, Bone
Applicant TRIAD MEDICAL, INC.
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact RITA GIEBEL
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 11/26/2001
Decision Date 12/17/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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