FDA 510(k)

波型L系統，波型TO系統，波型TA系統

K 號：K213420 · 2022-05-04

決定日期2022-05-04

產品代碼MAX

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器材摘要

WaveForm L System, WaveForm TO System, WaveForm TA 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 2022-05-04 under 510(k) number K213420. 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 WaveForm L System, WaveForm TO System, WaveForm TA System?

WaveForm L System, WaveForm TO System, WaveForm TA System is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K213420.

When did WaveForm L System, WaveForm TO System, WaveForm TA System receive FDA 510(k) clearance?

WaveForm L System, WaveForm TO System, WaveForm TA System received FDA 510(k) clearance on 2022-05-04, under 510(k) number K213420.

Who is the listed applicant for WaveForm L System, WaveForm TO System, WaveForm TA 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 WaveForm L System, WaveForm TO System, WaveForm TA System?

The FDA product code for WaveForm L System, WaveForm TO System, WaveForm TA 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 K240566Reef L 間體系統；WaveForm L 間體系統

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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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