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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
Alisa Viejo,  CA  92656
Applicant Contact REBECCA SHELBURNE WALKER
Correspondent
Nuvasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Correspondent Contact REBECCA SHELBURNE WALKER
Regulation Number888.3070
Classification Product Code
PGN  
Date Received06/24/2016
Decision Date 09/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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