FDA 510(k)

卡斯凱迪亞內固定系統

K 號：K160547 · 2016-03-24

申請人K2m

決定日期2016-03-24

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Cascadia Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is K2m. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K160547. 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 Cascadia Interbody System?

Cascadia Interbody System is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is K2m. The 510(k) number is K160547.

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

Cascadia Interbody System received FDA 510(k) clearance on 2016-03-24, under 510(k) number K160547.

Who is the listed applicant for Cascadia Interbody System?

The FDA 510(k) record lists K2m as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cascadia Interbody System?

The FDA product code for Cascadia Interbody System is MAX.

其他以 K2m 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。

K182182YUKON脊椎系統 K181890Brainlab 兼容 K2M 選向儀器 K172941CASCADIA 間隙系統 K171556K2M導航儀器 K173508埃佛勒斯脊椎系統 K171704CAPRI 胸椎切除籠架系統

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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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