FDA 510(k) Application Details - K172979

Device Classification Name

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510(K) Number K172979
Device Name NuVasive« Growth Rod Conversion Set
Applicant NuVasive, Incorporated
7475 Lusk Boulevard
San Diego, CA 92121 US
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Contact Olga Lewis
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Regulation Number

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Classification Product Code PGM
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Date Received 09/27/2017
Decision Date 11/06/2017
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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