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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name growing rod system- magnetic actuation
510(k) Number K161751
Device Name MAGEC® Spinal Bracing and Distraction System
Applicant
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 ENTERPRISE, SUITE 100
aliso viejo,  CA  92656
Applicant Contact rebecca shelburne walker
Correspondent
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 ENTERPRISE, SUITE 100
aliso viejo,  CA  92656
Correspondent Contact rebecca shelburne walker
Classification Product Code
PGN  
Date Received06/24/2016
Decision Date 09/02/2016
Decision substantially equivalent (SESE)
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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