FDA 510(k) Application Details - K020411

Device Classification Name System, Facet Screw Spinal Device

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510(K) Number K020411
Device Name System, Facet Screw Spinal Device
Applicant NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO, CA 92131 US
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Contact LAETITIA BERNARD
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Regulation Number 000.0000

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Classification Product Code MRW
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Date Received 02/07/2002
Decision Date 03/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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