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510(k) K243015

Skyway Anterior Cervical Plate System by Kyocera Medical Technologies, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2024
Date Received
September 27, 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

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