FDA 510(k)

安寧內固定系統

K 號：K181483 · 2018-08-27

決定日期2018-08-27

產品代碼MAX

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決定相當於

器材摘要

Tranquil 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 2018-08-27 under 510(k) number K181483. 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 Interbody System?

Tranquil Interbody System is a medical device that received FDA 510(k) clearance on 2018-08-27. The listed applicant is Nexus Spine, LLC. The 510(k) number is K181483.

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

Tranquil Interbody System received FDA 510(k) clearance on 2018-08-27, under 510(k) number K181483.

Who is the listed applicant for Tranquil 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 Interbody System?

The FDA product code for Tranquil 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 K233375Tranquil-L 間隙系統 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

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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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