FDA 510(k) Application Details - K112737

Device Classification Name Screw, Fixation, Bone

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510(K) Number K112737
Device Name Screw, Fixation, Bone
Applicant TRILLIANT SURGICAL LTD
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact J D WEBB
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 09/20/2011
Decision Date 10/20/2011
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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