FDA 510(k)

Reef L 間體系統；WaveForm L 間體系統

K 號：K240566 · 2024-04-26

決定日期2024-04-26

產品代碼MAX

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決定相當於

器材摘要

Reef L Interbody System; WaveForm L Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240566. 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 Reef L Interbody System; WaveForm L Interbody System?

Reef L Interbody System; WaveForm L Interbody System is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K240566.

When did Reef L Interbody System; WaveForm L Interbody System receive FDA 510(k) clearance?

Reef L Interbody System; WaveForm L Interbody System received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240566.

Who is the listed applicant for Reef L Interbody System; WaveForm L Interbody System?

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

What is the FDA product code for Reef L Interbody System; WaveForm L Interbody System?

The FDA product code for Reef L Interbody System; WaveForm L Interbody System is MAX.

其他以 SeaSpine Orthopedics Corporation 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。

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 System K250908維拉塔脊椎固定系統 K243659FLASH™ 髋節融合儀器，IsoTis® 髋節融合儀器 K242273Cove 黏土，OsteoCove 黏土 K241466Shoreline ACS 內固定系統；Shoreline RT 內固定系統；Regatta 旁路系統；Reef L 內固定系統；Reef TO/TA 系統；Meridian 內固定系統；WaveForm C 內固定系統；WaveForm L 內固定系統；WaveForm TO 內固定系統；WaveForm TA 內固定系統；WaveForm A 內固定系統 K232566NewPort脊椎系統；Daytona小型身材脊椎系統；Malibu脊椎系統；Mariner椎板螺釘系統：Mariner外擴修復系統；Mariner MIS椎板螺釘系統；Mariner畸形系統；Mariner RDX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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