FDA 510(k)

IdentiTi™ II ALIF 独立間盤系統；Transcend™ ALIF 独立間盤系統

K 號：K251575 · 2025-09-03

決定日期2025-09-03

產品代碼OVD

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器材摘要

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K251575. 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 IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Alphatec Spine. The 510(k) number is K251575.

When did IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System receive FDA 510(k) clearance?

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System received FDA 510(k) clearance on 2025-09-03, under 510(k) number K251575.

Who is the listed applicant for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

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

What is the FDA product code for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System?

The FDA product code for IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is OVD.

其他以 Alphatec 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。

K241375IdentiTi多孔Ti間隙系統；IdentiTi NanoTec間隙系統；IdentiTi頸椎多孔Ti間隙系統；IdentiTi NanoTec頸椎間隙系統；IdentiTi頸椎獨立間隙系統；IdentiTi NanoTec頸椎獨立間隙系統；IdentiTi ALIF獨立間隙系統；IdentiTi NanoTec ALIF獨立間隙系統；Transcend PEEK間隙系統；Transcend NanoTec間隙系統；Transcend頸椎PEEK間隙系統；Transcend NanoTec陶瓷 K240951無敵機器人導航儀器 K222028IdentiTi™多孔Ti間隙系統，IdentiTi™ NanoTec™間隙系統，Transcend™ PEEK間隙系統，Transcend™ NanoTec™間隙系統，IdentiTi™ ALIF單獨間隙系統，IdentiTi™ NanoTec™ ALIF單獨間隙系統 K191185索拉纳斯® 頸後部OCT固定系統 K160958Battalion 開放式隔離系統

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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