FDA 510(k) Application Details - K993067

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K993067
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant SULZER SPINE-TECH
7375 BUSH LAKE RD.
MINNEAPOLIS, MN 55439-2027 US
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Contact JANELL A COLLEY
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 09/13/1999
Decision Date 11/16/1999
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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