FDA 510(k)

穩定-L 独立腰椎間融合系統

K 號：K231486 · 2023-10-12

決定日期2023-10-12

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

Stable-L Standalone Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Nexus Spine, LLC. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K231486. 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 Stable-L Standalone Lumbar Interbody System?

Stable-L Standalone Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Nexus Spine, LLC. The 510(k) number is K231486.

When did Stable-L Standalone Lumbar Interbody System receive FDA 510(k) clearance?

Stable-L Standalone Lumbar Interbody System received FDA 510(k) clearance on 2023-10-12, under 510(k) number K231486.

Who is the listed applicant for Stable-L Standalone Lumbar Interbody System?

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

What is the FDA product code for Stable-L Standalone Lumbar Interbody System?

The FDA product code for Stable-L Standalone Lumbar Interbody System is OVD.

其他以 Nexus Spine, LLC 為申請人之記錄

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K243934穩定-L 腰椎間盤系統 K241467穩定-C 間體系統 K233375Tranquil-L 間隙系統 K240416Tranquil-C 間隙系統 K233234PressON脊椎固定系統 K232530穩定-L獨立腰椎間系統，穩定-C腰椎間系統

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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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