FDA 510(k)

Tranquil-L 間隙系統

K 號：K233375 · 2024-03-20

決定日期2024-03-20

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Tranquil-L 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 2024-03-20 under 510(k) number K233375. 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 Tranquil-L Interbody System?

Tranquil-L Interbody System is a medical device that received FDA 510(k) clearance on 2024-03-20. The listed applicant is Nexus Spine, LLC. The 510(k) number is K233375.

When did Tranquil-L Interbody System receive FDA 510(k) clearance?

Tranquil-L Interbody System received FDA 510(k) clearance on 2024-03-20, under 510(k) number K233375.

Who is the listed applicant for Tranquil-L 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 Tranquil-L Interbody System?

The FDA product code for Tranquil-L Interbody System is MAX.

其他以 Nexus Spine, LLC 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。

K243934穩定-L 腰椎間盤系統 K241467穩定-C 間體系統 K240416Tranquil-C 間隙系統 K233234PressON脊椎固定系統 K231486穩定-L 独立腰椎間融合系統 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：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。

K261049SCALA® TLSpineart SA K261430TruLift可擴展系統Life Spine, Inc.K253011Catalyft PL 可擴展椎間體系統Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L脊椎系統Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

官方來源

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