FDA 510(k)

導管側邊開關板

K 號：K221325 · 2022-08-25

決定日期2022-08-25

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

CONDUIT Lateral Switch Plate is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K221325. 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 CONDUIT Lateral Switch Plate?

CONDUIT Lateral Switch Plate is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Medos International SARL. The 510(k) number is K221325.

When did CONDUIT Lateral Switch Plate receive FDA 510(k) clearance?

CONDUIT Lateral Switch Plate received FDA 510(k) clearance on 2022-08-25, under 510(k) number K221325.

Who is the listed applicant for CONDUIT Lateral Switch Plate?

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

What is the FDA product code for CONDUIT Lateral Switch Plate?

The FDA product code for CONDUIT Lateral Switch Plate is MAX.

其他以 Medos International SARL 為申請人之記錄

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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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