FDA 510(k)

脊椎導引 5.3 軟體；Q 間體儀器；Elite Q 附件；Elite 切割附件

K 號：K252871 · 2026-02-06

決定日期2026-02-06

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K252871. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories?

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K252871.

When did Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories receive FDA 510(k) clearance?

Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories received FDA 510(k) clearance on 2026-02-06, under 510(k) number K252871.

Who is the listed applicant for Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories?

The FDA product code for Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories is OLO.

其他以 Stryker Leibinger GmbH & Co KG 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261054肋骨板系統 K254233醫用設備規範文本翻譯： MEDPOR客製化植入套件 K253623脊椎導引 5.4 軟體；脊椎導引 5.4 升級；脊椎導引 5.4 更新；脊椎導引 5.4 軟體啟用；脊椎導引 5.4 買賣展示；Q 閼钻追踪器；NavLock 适配器；Elite Q 附件；Elite 切割附件；Maestro 空氣馬達 K243491胸骨板擴張 K241517Q導向系統；Mako脊椎系統；K241171脊椎導航軟體（版本 5.1）；整合手術室設備（CORE）2 控制台；CORE Q 靈敏踏板；PI Drive 2 馬達；Elite Q 附件及切割附件

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相關器械（代碼：OLO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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