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510(k) K172086

Matira™ Anterior Cervical System by Kalitec Direct, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2017
Date Received
July 11, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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  • K133815 — INTESS CERVICAL CAGE SYSTEM (April 16, 2014)
  • K123100 — INTESS LUMBAR CAGE (March 28, 2013)
  • K111370 — ODALYS PEDICLE SCREW SYSTEM (September 21, 2011)

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