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FDA 510(k) Application Details - K162944
Device Classification Name
More FDA Info for this Device
510(K) Number
K162944
Device Name
Irix-C Cervical Integrated Fusion System
Applicant
X-SPINE SYSTEMS, INC.
452 ALEXANDERSVILLE RD.
MIAMISBURG, OH 45342 US
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Contact
KRISS ANDERSSON
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVE
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More FDA Info for this Product Code
Date Received
10/21/2016
Decision Date
11/07/2016
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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