FDA 510(k)

SIRION 横向腰椎間融合器

K 號：K202495 · 2021-01-06

決定日期2021-01-06

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

SIRION Lateral Lumbar Interbody Fusion is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical, LLC. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K202495. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SIRION Lateral Lumbar Interbody Fusion?

SIRION Lateral Lumbar Interbody Fusion is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Astura Medical, LLC. The 510(k) number is K202495.

When did SIRION Lateral Lumbar Interbody Fusion receive FDA 510(k) clearance?

SIRION Lateral Lumbar Interbody Fusion received FDA 510(k) clearance on 2021-01-06, under 510(k) number K202495.

Who is the listed applicant for SIRION Lateral Lumbar Interbody Fusion?

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

What is the FDA product code for SIRION Lateral Lumbar Interbody Fusion?

The FDA product code for SIRION Lateral Lumbar Interbody Fusion is MAX.

其他以 Astura Medical, 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。

K202065多羅米特前頸穩定系統 K192492EL CAPITAN 前腰椎間植骨系統 K192006SIRION 横向腰椎間盤系統 K190426ALTA 前頸椎切除系統 K182877HALF DOME 背部腰椎間植入系統 K182239奧林匹克後脊椎固定系統

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相關器械（代碼：MAX）

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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