FDA 510(k)

Camber 骨盆釘定系統

K 號：K233972 · 2024-02-27

決定日期2024-02-27

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

Camber Sacroiliac (SI) Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2024-02-27 under 510(k) number K233972. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Camber Sacroiliac (SI) Fixation System?

Camber Sacroiliac (SI) Fixation System is a medical device that received FDA 510(k) clearance on 2024-02-27. The listed applicant is Camber Spine Technologies. The 510(k) number is K233972.

When did Camber Sacroiliac (SI) Fixation System receive FDA 510(k) clearance?

Camber Sacroiliac (SI) Fixation System received FDA 510(k) clearance on 2024-02-27, under 510(k) number K233972.

Who is the listed applicant for Camber Sacroiliac (SI) Fixation System?

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

What is the FDA product code for Camber Sacroiliac (SI) Fixation System?

The FDA product code for Camber Sacroiliac (SI) Fixation System is OUR.

其他以 Camber Spine Technologies 為申請人之記錄

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相關器械（代碼：OUR）

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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