FDA 510(k) Application Details - K102547

Device Classification Name

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510(K) Number K102547
Device Name COROENT INTERLOCK SYSTEM
Applicant NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121 US
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Contact Sheila Bruschi
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Regulation Number

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Classification Product Code OVE
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Date Received 09/03/2010
Decision Date 02/07/2011
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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