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FDA 510(k) Application Details - K150913
Device Classification Name
More FDA Info for this Device
510(K) Number
K150913
Device Name
INCITE ANCHORED CERVICAL INTERBODY DEVICE
Applicant
INCITE INNOVATION
1500 MAIN STREET, SUITE 2410
SPRINGFIELD, MA 01115-5707 US
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Contact
JOHN KIRWAN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2015
Decision Date
04/30/2015
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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