FDA 510(k)

托羅-L 間體融合系統

K 號：K213355 · 2022-03-25

決定日期2022-03-25

產品代碼MAX

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決定相當於

器材摘要

Toro-L Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Implants, Inc.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K213355. 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 Toro-L Interbody Fusion System?

Toro-L Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Integrity Implants, Inc.. The 510(k) number is K213355.

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

Toro-L Interbody Fusion System received FDA 510(k) clearance on 2022-03-25, under 510(k) number K213355.

Who is the listed applicant for Toro-L Interbody Fusion System?

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

What is the FDA product code for Toro-L Interbody Fusion System?

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

其他以 Integrity Implants, Inc. 為申請人之記錄

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K231098LineSider®脊椎系統 K220453FlareHawk 間隙融合系統 K212088Integrity Implants 精準導向儀器 K203038托羅-L 間體融合系統 K203367LineSider™脊椎系統 K202198FlareHawk 間隙融合系統

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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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