FDA 510(k) Application Details - K070906

Device Classification Name Screw, Fixation, Bone

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510(K) Number K070906
Device Name Screw, Fixation, Bone
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact MASON W ROBBINS
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 04/02/2007
Decision Date 05/01/2007
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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