Skyway Anterior Cervical Plate System

FDA 510(k) K250486 · Kyocera Medical Technologies Inc. (KMTI)

Substantially Equivalent

510(k) numberK250486

Submission

Device name
Skyway Anterior Cervical Plate System
Applicant
Kyocera Medical Technologies Inc. (KMTI)
Redlands, CA, US
Received
February 19, 2025
Decision date
April 10, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWQ – Appliance, Fixation, Spinal Intervertebral Body
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWQ

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K261309Palisades™ Buttress Plate SystemKWQ · Traditional Bethesda Medical Devices, LLC07/16/2026SE
K252776ARIES Anterior Cervical Plate SystemsKWQ · Traditional ZheJiang Decans Medical Devices Co., Ltd.05/14/2026SE
K261112CastleLoc-P Anterior Cervical Plate SystemKWQ · Special L&K BIOMED Co., Ltd.05/06/2026SE
K260570corra™ cervical plating systemKWQ · Traditional Carlsmed, Inc.04/22/2026SE
K260697VyPlate™ Anterior Cervical Plate SystemKWQ · Special Vy Spine, LLC03/27/2026SE
K260015ANTERIS Thoracolumbar Plate SystemKWQ · Traditional SpineCraft03/04/2026SE
K251940PathLoc Lumbar Plate SystemKWQ · Traditional L&K BIOMED Co., Ltd.03/03/2026SE
K254182AsterKWQ · Traditional Osteonic Co., Ltd.02/26/2026SE
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special 4Web, Inc.02/12/2026SE
K252611aprevo® cervical plating systemKWQ · Traditional Carlsmed, Inc.12/22/2025SE

More from Carlsmed, Inc.

510(k)DeviceDecision
K260989Varion Thoracolumbar Fixation SystemNKB · Traditional 05/15/2026SE
K231766Skyway Anterior Cervical Plate SystemKWQ · Traditional 09/12/2023SE

Questions and answers

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

Skyway Anterior Cervical Plate System (K250486) received a 510(k) decision of Substantially Equivalent on April 10, 2025, 50 days after the submission was received.

What is the product code of K250486?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.