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FDA 510(k)

Skyway Anterior Cervical Plate System

K-Number: K231766 · 2023-09-12

ApplicantKyocera Medical Technologies Inc. (KMTI)
Decision Date2023-09-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Skyway Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies Inc. (KMTI). It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K231766. 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 2023-09-12. The listed applicant is Kyocera Medical Technologies Inc. (KMTI). The 510(k) number is K231766.

When did Skyway Anterior Cervical Plate System receive FDA 510(k) clearance?

Skyway Anterior Cervical Plate System received FDA 510(k) clearance on 2023-09-12, under 510(k) number K231766.

Who is the listed applicant for Skyway Anterior Cervical Plate System?

The FDA 510(k) record lists Kyocera Medical Technologies Inc. (KMTI) as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Kyocera Medical Technologies Inc. (KMTI) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260989Varion Thoracolumbar Fixation SystemK250486Skyway Anterior Cervical Plate System

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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