FDA 510(k)

Genesys脊椎3DP頸椎間盤系統

K 號：K191489 · 2020-01-08

決定日期2020-01-08

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Genesys Spine 3DP Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2020-01-08 under 510(k) number K191489. 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 Genesys Spine 3DP Cervical Interbody System?

Genesys Spine 3DP Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2020-01-08. The listed applicant is Genesys Spine. The 510(k) number is K191489.

When did Genesys Spine 3DP Cervical Interbody System receive FDA 510(k) clearance?

Genesys Spine 3DP Cervical Interbody System received FDA 510(k) clearance on 2020-01-08, under 510(k) number K191489.

Who is the listed applicant for Genesys Spine 3DP Cervical Interbody System?

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

What is the FDA product code for Genesys Spine 3DP Cervical Interbody System?

The FDA product code for Genesys Spine 3DP Cervical Interbody System is OVE.

其他以 Genesys Spine 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。

K252322西羅斯-X系統 K242483Genesys脊椎AIS-C II頸椎間融合系統 K233595Genesys脊椎骨盆關節融合系統配導航 K233594Genesys Spine 3DP AIS-C II 頸椎間盤系統 K220096Genesys Spine 3DP 腰椎間盤系統 K182987Genesys Spine 3DP 腰椎間盤系統

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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 Spine K261882Pisces-SC 独立颈椎間盤系統Osseus Fusions Systems, LLC K261451ZSAlign脊椎間盤系統ZSFab, Inc.K262094E3D™-C 間體系統Evolution Spine K261279DeltaNEC 間隙系統Nexus Spine K252982CONDUIT™ 零-P™ 維護隔離系統Avalign Technologies, Inc.

官方來源

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