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FDA 510(k) Application Details - K121924
Device Classification Name
More FDA Info for this Device
510(K) Number
K121924
Device Name
INTEGRA INTERSPINOUS PROCESS SYSTEM
Applicant
SEASPINE, INC.
2302 la Mirada Dr
VISTA, CA 92081 US
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Contact
NICK M CORDARO
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Regulation Number
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Classification Product Code
PEK
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Date Received
07/02/2012
Decision Date
09/04/2013
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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