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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 K201543
Device Name MAGEC® System
Applicant
NuVasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Aliso Viejo,  CA  92656
Applicant Contact Ivanna Lopez
Correspondent
NuVasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact Ivanna Lopez
Regulation Number888.3070
Classification Product Code
PGN  
Date Received06/09/2020
Decision Date 07/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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