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FDA 510(k)

Shoreline ACS間隔系統；Shoreline RT間隔系統

K 號：K233414 · 2023-11-28

申請人SeaSpine Orthopedics Corporation
決定日期2023-11-28
產品代碼OVE
諮詢委員會或
決定相當於

器材摘要

Shoreline ACS Interbody System; Shoreline RT 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 2023-11-28 under 510(k) number K233414. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Shoreline ACS Interbody System; Shoreline RT Interbody System?

Shoreline ACS Interbody System; Shoreline RT Interbody System is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K233414.

When did Shoreline ACS Interbody System; Shoreline RT Interbody System receive FDA 510(k) clearance?

Shoreline ACS Interbody System; Shoreline RT Interbody System received FDA 510(k) clearance on 2023-11-28, under 510(k) number K233414.

Who is the listed applicant for Shoreline ACS Interbody System; Shoreline RT 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 Shoreline ACS Interbody System; Shoreline RT Interbody System?

The FDA product code for Shoreline ACS Interbody System; Shoreline RT Interbody System is OVE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 SystemK250908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：OVE）

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。

K263049SABER-C 系統Elevation SpineK261882Pisces-SC 独立颈椎間盤系統Osseus Fusions Systems, LLCK261451ZSAlign脊椎間盤系統ZSFab, Inc.K262094E3D™-C 間體系統Evolution SpineK261279DeltaNEC 間隙系統Nexus SpineK252982CONDUIT™ 零-P™ 維護隔離系統Avalign Technologies, Inc.

官方來源

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