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FDA 510(k)

Skyway Anterior Cervical Plate System

K-Number: K250486 · 2025-04-10

ApplicantKyocera Medical Technologies Inc. (KMTI)
Decision Date2025-04-10
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Skyway Anterior Cervical Plate System is a medical device manufactured by Kyocera Medical Technologies Inc. (KMTI). It received FDA 510(k) clearance on 2025-04-10 under approval number K250486. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Skyway Anterior Cervical Plate System?

Skyway Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by Kyocera Medical Technologies Inc. (KMTI). The 510(k) number is K250486.

When was Skyway Anterior Cervical Plate System approved by the FDA?

Skyway Anterior Cervical Plate System received FDA 510(k) clearance on 2025-04-10, under approval number K250486.

What company makes Skyway Anterior Cervical Plate System?

Skyway Anterior Cervical Plate System is manufactured by Kyocera Medical Technologies Inc. (KMTI).

What is the FDA product code for Skyway Anterior Cervical Plate System?

The FDA product code for Skyway Anterior Cervical Plate System is KWQ.

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Other Devices by Kyocera Medical Technologies Inc. (KMTI)

K231766Skyway Anterior Cervical Plate System K260989Varion Thoracolumbar Fixation System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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