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510(k) K142558

Caspian OCT/MESA Mini/DENALI Mini Spinal System by K2m — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2014
Date Received
September 11, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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