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FDA 510(k) Application Details - K131427
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K131427
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SPINAL ELEMENTS, INC.
3115 MELROSE DRIVE STE 200
CARLSBAD, CA 92010 US
Other 510(k) Applications for this Company
Contact
BENJAMIN A KIMBALL
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2013
Decision Date
10/24/2013
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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