FDA 510(k)

SIMPACT 骨盆釘合系統 GX 運導儀器

K 號：K260571 · 2026-06-02

決定日期2026-06-02

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

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K260571. 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 SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments?

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Life Spine, Inc.. The 510(k) number is K260571.

When did SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments receive FDA 510(k) clearance?

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments received FDA 510(k) clearance on 2026-06-02, under 510(k) number K260571.

Who is the listed applicant for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments?

FDA 510(k) 記錄將 Life Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments?

The FDA product code for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments is OLO.

其他以 Life Spine, Inc. 為申請人之記錄

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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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