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510(k) K240484

MSFX Mikron Cervical Anterior Plate System by Mikron Makina Sanayi VE Ticaret Ltd. Sti. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2024
Date Received
February 20, 2024
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

Other clearances by Mikron Makina Sanayi VE Ticaret Ltd. Sti.

  • K241657 — MSFX MIKRON SPINAL FIXATION SYSTEM (September 30, 2024)
  • K130073 — MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL (December 16, 2013)

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