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510(k) K250486

Skyway Anterior Cervical Plate System by Kyocera Medical Technologies Inc. (KMTI) — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2025
Date Received
February 19, 2025
Clearance Type
Special
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 Kyocera Medical Technologies Inc. (KMTI)

  • K231766 — Skyway Anterior Cervical Plate System (September 12, 2023)

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