FDA 510(k)

Adaptix Interbody System with Titan nanoLOCK Surface Technology

K 號：K201267 · 2020-08-26

決定日期2020-08-26

產品代碼MAX

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器材摘要

Adaptix Interbody System with Titan nanoLOCK Surface Technology is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K201267. 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 Adaptix Interbody System with Titan nanoLOCK Surface Technology?

Adaptix Interbody System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K201267.

When did Adaptix Interbody System with Titan nanoLOCK Surface Technology receive FDA 510(k) clearance?

Adaptix Interbody System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2020-08-26, under 510(k) number K201267.

Who is the listed applicant for Adaptix Interbody System with Titan nanoLOCK Surface Technology?

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

What is the FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology?

The FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology is MAX.

其他以 Medtronic Sofamor Danek 為申請人之記錄

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K212428中心板固定系統 K173125T2 STRATOSPHERE™ 可擴展椎體切除系統 K172199ELEVATE脊椎系統，CAPSTONE PTC脊椎系統，CRESCENT脊椎系統，CRESCENT脊椎系統钛版 K171031新月™脊椎系統 K171468FUSE脊椎系統 K170679CD HORIZON®脊椎系統，與IPC® POWEREASE®系統配合使用的Medtronic可重用儀器，與STEALTHSTATION®及IPC® POWEREASE®系統配合使用的Medtronic導航可重用儀器

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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.

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