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FDA 510(k) Application Details - K112206
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K112206
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SEASPINE, INC.
2302 LA MIRADA DR.
VISTA, CA 92081-7862 US
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Contact
DAN MILLER
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2011
Decision Date
01/25/2012
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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