FDA 510(k) Application Details - K093319

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K093319
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121 US
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Contact Sheila Bruschi
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 10/23/2009
Decision Date 06/23/2010
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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