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FDA 510(k) Application Details - K131156
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K131156
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
LANX, INC.
310 INTERLOCKEN PARKWAY
SUITE 120
BROOMFIELD, CO 80021 US
Other 510(k) Applications for this Company
Contact
MICHAEL MEDINA
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
04/24/2013
Decision Date
05/24/2013
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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