FDA 510(k)

南側經椎間孔腰椎間融合術（TLIF）

K 號：K221182 · 2022-12-08

決定日期2022-12-08

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Southern Transforaminal Lumbar Interbody Fusion (TLIF) is the device name listed in this FDA 510(k) record. The listed applicant is Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K221182. 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 Southern Transforaminal Lumbar Interbody Fusion (TLIF)?

Southern Transforaminal Lumbar Interbody Fusion (TLIF) is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K221182.

When did Southern Transforaminal Lumbar Interbody Fusion (TLIF) receive FDA 510(k) clearance?

Southern Transforaminal Lumbar Interbody Fusion (TLIF) received FDA 510(k) clearance on 2022-12-08, under 510(k) number K221182.

Who is the listed applicant for Southern Transforaminal Lumbar Interbody Fusion (TLIF)?

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

What is the FDA product code for Southern Transforaminal Lumbar Interbody Fusion (TLIF)?

The FDA product code for Southern Transforaminal Lumbar Interbody Fusion (TLIF) is MAX.

其他以 Southern Medical (Pty) , Ltd. 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：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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