FDA 510(k)

昇高脊椎薩貝爾-C系統

K 號：K190885 · 2019-08-07

決定日期2019-08-07

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Elevation Spine Saber-C System is the device name listed in this FDA 510(k) record. The listed applicant is Elevation Spine. It received FDA 510(k) clearance on 2019-08-07 under 510(k) number K190885. 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 Elevation Spine Saber-C System?

Elevation Spine Saber-C System is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Elevation Spine. The 510(k) number is K190885.

When did Elevation Spine Saber-C System receive FDA 510(k) clearance?

Elevation Spine Saber-C System received FDA 510(k) clearance on 2019-08-07, under 510(k) number K190885.

Who is the listed applicant for Elevation Spine Saber-C System?

FDA 510(k) 記錄將 Elevation Spine 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Elevation Spine Saber-C System?

The FDA product code for Elevation Spine Saber-C System is OVE.

其他以 Elevation 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。

K263049SABER-C 系統 K261408SABER-XA 系統 K260660SABER-C 系統 K250540SABER-C 系統

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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