FDA 510(k)

Triton™ 骨盆釘合系統

K 號：K211449 · 2021-08-31

決定日期2021-08-31

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

Triton™ Sacroiliac Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Choice Spine, LLC. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K211449. 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 Triton™ Sacroiliac Joint Fixation System?

Triton™ Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Choice Spine, LLC. The 510(k) number is K211449.

When did Triton™ Sacroiliac Joint Fixation System receive FDA 510(k) clearance?

Triton™ Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2021-08-31, under 510(k) number K211449.

Who is the listed applicant for Triton™ Sacroiliac Joint Fixation System?

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

What is the FDA product code for Triton™ Sacroiliac Joint Fixation System?

The FDA product code for Triton™ Sacroiliac Joint Fixation System is OUR.

其他以 Choice Spine, LLC 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。

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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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