FDA 510(k) Application Details - K031685

Device Classification Name Screw, Fixation, Bone

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510(K) Number K031685
Device Name Screw, Fixation, Bone
Applicant SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD, MA 02048 US
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Contact JASON BILOBRAM
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 06/02/2003
Decision Date 07/01/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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