FDA 510(k)

Erisma® Lp脊椎固定系統；Erisma® LP MIS

K 號：K241863 · 2024-07-24

決定日期2024-07-24

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Erisma® Lp Spinal Fixation System; Erisma® LP MIS is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241863. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Erisma® Lp Spinal Fixation System; Erisma® LP MIS?

Erisma® Lp Spinal Fixation System; Erisma® LP MIS is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Clariance. The 510(k) number is K241863.

When did Erisma® Lp Spinal Fixation System; Erisma® LP MIS receive FDA 510(k) clearance?

Erisma® Lp Spinal Fixation System; Erisma® LP MIS received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241863.

Who is the listed applicant for Erisma® Lp Spinal Fixation System; Erisma® LP MIS?

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

What is the FDA product code for Erisma® Lp Spinal Fixation System; Erisma® LP MIS?

The FDA product code for Erisma® Lp Spinal Fixation System; Erisma® LP MIS is NKB.

其他以 Clariance 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。

K243904Elegance® 前頸板 K243670Idys® LIF K240872Erisma® 叭曲脊椎系統；Erisma® Lp 脊椎固定系統 K240715Idys® C ZP 3DTi K220182Aggeris™-C K200919Idys ALIF 3DTi

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相關器械（代碼：NKB）

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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