FDA 510(k)

クロスナビネーション機能付きディスク準備およびインターボディ用機器

K番号: K254157 · 2026-05-26

決定日2026-05-26

製品コードOLO

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K254157. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody?

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Medos International SARL. The 510(k) number is K254157.

When did CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody receive FDA 510(k) clearance?

CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody received FDA 510(k) clearance on 2026-05-26, under 510(k) number K254157.

Who is the listed applicant for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody?

The FDA product code for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody is OLO.

申請者としてMedos International SARLを記載するその他の記録

K260240シンフォニーナビゲーションレディインストルメンツ K253249TriALTIS™脊椎システム K243249TriALTIS™脊椎システム K241893クロスナビ・ナビゲーション対応機器およびユナス・ナビゲーションアレイ K242042TriALTIS™脊椎システム K233684TriALTIS™脊椎システム

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