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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 K171791
Device Name MAGEC® System
Applicant
Nuvasive Specialized Orthopedics, Incorporated
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Applicant Contact Manthan J. Damani
Correspondent
Nuvasive Specialized Orthopedics, Incorporated
101 Enterprise, Suite 100
Alisa Viejo,  CA  92656
Correspondent Contact Manthan J. Damani
Regulation Number888.3070
Classification Product Code
PGN  
Date Received06/16/2017
Decision Date 08/31/2017
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
Recalls CDRH Recalls
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