FDA 510(k) Application Details - K033233

Device Classification Name Screw, Fixation, Bone

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510(K) Number K033233
Device Name Screw, Fixation, Bone
Applicant BIOMET, INC.
56 BELL DR.
PO BOX 587
WARSAW, IN 46581-0587 US
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Contact PATRICIA SANDBORN BERES
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 10/06/2003
Decision Date 11/05/2003
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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