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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 K140178
Device Name ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Applicant
ELLIPSE TECHNOLOGIES, INC.
13900 ALTON PARKWAY
SUITE 123
IRVINE,  CA  92618
Applicant Contact John McIntyre
Correspondent
ELLIPSE TECHNOLOGIES, INC.
13900 ALTON PARKWAY
SUITE 123
IRVINE,  CA  92618
Correspondent Contact John McIntyre
Regulation Number888.3070
Classification Product Code
PGN  
Date Received01/24/2014
Decision Date 02/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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