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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 K140613
Device Name MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Applicant
Ellipse Technologies, Inc.
13900 Alton Pkwy. Suite 123
Irvine,  CA  92618 -0000
Applicant Contact John McIntyre
Correspondent
Ellipse Technologies, Inc.
13900 Alton Pkwy. Suite 123
Irvine,  CA  92618 -0000
Correspondent Contact John McIntyre
Regulation Number888.3070
Classification Product Code
PGN  
Date Received03/10/2014
Decision Date 09/18/2014
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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