FDA 510(k)

羅梅羅頸椎金屬支架

K 號：K212358 · 2022-01-10

決定日期2022-01-10

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Romero Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Spineup, Inc.. It received FDA 510(k) clearance on 2022-01-10 under 510(k) number K212358. 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 Romero Cervical Cage?

Romero Cervical Cage is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is Spineup, Inc.. The 510(k) number is K212358.

When did Romero Cervical Cage receive FDA 510(k) clearance?

Romero Cervical Cage received FDA 510(k) clearance on 2022-01-10, under 510(k) number K212358.

Who is the listed applicant for Romero Cervical Cage?

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

What is the FDA product code for Romero Cervical Cage?

The FDA product code for Romero Cervical Cage is OVE.

其他以 Spineup, Inc. 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。

K250446Frida™ 頸前板系統

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。