FDA 510(k)

AxTiHA® 独立 ALIF 系統

K 號：K250603 · 2025-03-24

決定日期2025-03-24

產品代碼OVD

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決定相當於

器材摘要

AxTiHA® Stand-Alone ALIF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K250603. 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 AxTiHA® Stand-Alone ALIF System?

AxTiHA® Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Innovasis. The 510(k) number is K250603.

When did AxTiHA® Stand-Alone ALIF System receive FDA 510(k) clearance?

AxTiHA® Stand-Alone ALIF System received FDA 510(k) clearance on 2025-03-24, under 510(k) number K250603.

Who is the listed applicant for AxTiHA® Stand-Alone ALIF System?

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

What is the FDA product code for AxTiHA® Stand-Alone ALIF System?

The FDA product code for AxTiHA® Stand-Alone ALIF System is OVD.

其他以 Innovasis 為申請人之記錄

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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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