FDA 510(k)

ネックチューン™ 3D SA 頸椎カイジ

K番号: K260036 · 2026-06-15

決定日2026-06-15

製品コードOVE

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

NeckTune™ 3D SA Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260036. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NeckTune™ 3D SA Cervical Cage?

NeckTune™ 3D SA Cervical Cage is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K260036.

When did NeckTune™ 3D SA Cervical Cage receive FDA 510(k) clearance?

NeckTune™ 3D SA Cervical Cage received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260036.

Who is the listed applicant for NeckTune™ 3D SA Cervical Cage?

The FDA 510(k) record lists Medyssey Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeckTune™ 3D SA Cervical Cage?

The FDA product code for NeckTune™ 3D SA Cervical Cage is OVE.

申請者としてMedyssey Co, Ltd.を記載するその他の記録

K242806メディサイド・ナビゲーション・システム

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