FDA 510(k) Application Details - K132504

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K132504
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant CORELINK LLC
1331 H STREET NW, 12TH FLOOR
WASHINGTON, DC 20005 US
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Contact JUSTIN EGGLETON
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 08/12/2013
Decision Date 11/25/2013
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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