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FDA 510(k)

SeaSpine Shoreline ACS - Anterior Cervical Standalone System

K 號：K161081 · 2016-09-14

申請人SeaSpine Orthopedics Corporation
決定日期2016-09-14
產品代碼OVE
諮詢委員會OR
決定Substantially Equivalent

器材摘要

SeaSpine Shoreline ACS - Anterior Cervical Standalone 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 2016-09-14 under 510(k) number K161081. 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 SeaSpine Shoreline ACS - Anterior Cervical Standalone System?

SeaSpine Shoreline ACS - Anterior Cervical Standalone System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K161081.

When did SeaSpine Shoreline ACS - Anterior Cervical Standalone System receive FDA 510(k) clearance?

SeaSpine Shoreline ACS - Anterior Cervical Standalone System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K161081.

Who is the listed applicant for SeaSpine Shoreline ACS - Anterior Cervical Standalone 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 SeaSpine Shoreline ACS - Anterior Cervical Standalone System?

The FDA product code for SeaSpine Shoreline ACS - Anterior Cervical Standalone 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。

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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 SyK250908Virata Spinal Fixation SystemK243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsK242273Cove Putty, OsteoCove PuttyK241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody SystemK240566Reef L Interbody System; WaveForm L Interbody System

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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 SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

官方來源

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