FDA 510(k) Application Details - K022952

Device Classification Name Screw, Fixation, Bone

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510(K) Number K022952
Device Name Screw, Fixation, Bone
Applicant BIOMET, INC.
56 EAST BELL DR.
WARSAW, IN 46581-0587 US
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Contact KACY ARNOLD
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 09/05/2002
Decision Date 12/02/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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