FDA 510(k) Application Details - K962314

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K962314
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant OSTEONICS CORP.
59 ROUTE 17
ALLENDALE, NJ 07401-1677 US
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Contact CHARLES RYAN
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 06/17/1996
Decision Date 12/09/1996
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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