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FDA 510(k) Application Details - K131522
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K131522
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
CORE-NEXUS
14001 HUNTERS PASS
AUSTIN, TX 78734 US
Other 510(k) Applications for this Company
Contact
LISA PETERSON
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/2013
Decision Date
08/09/2013
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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