FDA 510(k) Application Details - K131156

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K131156
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant LANX, INC.
310 INTERLOCKEN PARKWAY
SUITE 120
BROOMFIELD, CO 80021 US
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Contact MICHAEL MEDINA
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Regulation Number 888.3050

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Classification Product Code KWP
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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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