FDA 510(k) Application Details - K192582

Device Classification Name

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510(K) Number K192582
Device Name NuVasive CoRoent Small Interlock System
Applicant NuVasive, Incorporated
7475 Lusk Blvd.
San Diego, CA 92121 US
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Contact Jessica LeBlanc
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Regulation Number

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Classification Product Code OVE
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Date Received 09/19/2019
Decision Date 11/13/2019
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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