FDA 510(k)

獨立式ALIF間盤融合系統

K 號：K221936 · 2022-10-17

決定日期2022-10-17

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Standalone ALIF Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221936. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Standalone ALIF Interbody Fusion System?

Standalone ALIF Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Eminent Spine. The 510(k) number is K221936.

When did Standalone ALIF Interbody Fusion System receive FDA 510(k) clearance?

Standalone ALIF Interbody Fusion System received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221936.

Who is the listed applicant for Standalone ALIF Interbody Fusion System?

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

What is the FDA product code for Standalone ALIF Interbody Fusion System?

The FDA product code for Standalone ALIF Interbody Fusion System is OVD.

其他以 Eminent Spine 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。

K250894顯赫脊柱後方SI系統 K241663優秀脊柱3D钛合金椎板螺釘系統 K242069顯赫脊柱側彎曲變形椎板螺釘系統 K212701優秀脊柱3D頸椎間融合系統

相關器械（代碼：OVD）

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。

K262025Innovasis AxTiHA® 独立式 ALIF 系統；Innovasis TxTiHA® IBF 系統；Innovasis HAtetracell®-C 鈦金屬頸椎 IBF 系統INNO Holdings Inc. DBA Innovasis K261408SABER-XA 系統Elevation Spine K261809Interwedge® 独立側邊架Foundation Surgical Group K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統Kyocera Medical Technologies, Inc.K260810Anteralign LS 盖板Tyber Medical, LLC K254202MectaLIF 3D金屬前臍Medacta International S.A.

官方來源

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