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FDA 510(k) Application Details - K140715
Device Classification Name
More FDA Info for this Device
510(K) Number
K140715
Device Name
ZIP MIS INTERSPINOUS FUSION SYSTEM
Applicant
AURORA SPINE, INC.
1331 H STREET NW 12TH FLOOR
WASHINGTON, DC 20005 US
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Contact
JUSTI N EGGLETON
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2014
Decision Date
04/17/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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