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FDA 510(k) Application Details - K140178
Device Classification Name
More FDA Info for this Device
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 US
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Contact
John McIntyre
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Regulation Number
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Classification Product Code
PGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/24/2014
Decision Date
02/27/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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