FDA 510(k)

EVOL脊椎間置系統

K 號：K200991 · 2020-05-13

決定日期2020-05-13

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

EVOL Spinal Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K200991. 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 EVOL Spinal Interbody System?

EVOL Spinal Interbody System is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Cutting Edge Spine, LLC. The 510(k) number is K200991.

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

EVOL Spinal Interbody System received FDA 510(k) clearance on 2020-05-13, under 510(k) number K200991.

Who is the listed applicant for EVOL Spinal Interbody System?

The FDA 510(k) record lists Cutting Edge Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOL Spinal Interbody System?

The FDA product code for EVOL Spinal Interbody System is MAX.

其他以 Cutting Edge 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。

K250605EVOL® ha – 高頸椎間融合系統 K230689T-FIX™ 3DSI 骨關節融合系統 K214123T-FIX® 3DSI 骨關節融合系統 K200552EVOS腰椎間植入系統 K192497EVOL ha - D 間隙融合系統 K190025EVOL® - 骨盆關節融合系統

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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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