FDA 510(k)

UniSpace® 獨立式C籠

K 號：K234119 · 2024-04-19

決定日期2024-04-19

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

UniSpace® Stand-Alone C Cage is the device name listed in this FDA 510(k) record. The listed applicant is Innosys Co., Ltd.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K234119. 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 UniSpace® Stand-Alone C Cage?

UniSpace® Stand-Alone C Cage is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Innosys Co., Ltd.. The 510(k) number is K234119.

When did UniSpace® Stand-Alone C Cage receive FDA 510(k) clearance?

UniSpace® Stand-Alone C Cage received FDA 510(k) clearance on 2024-04-19, under 510(k) number K234119.

Who is the listed applicant for UniSpace® Stand-Alone C Cage?

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

What is the FDA product code for UniSpace® Stand-Alone C Cage?

The FDA product code for UniSpace® Stand-Alone C Cage is OVE.

其他以 Innosys Co., Ltd. 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。

K241082INNOVERSE導航儀器 K233960INNOVERSE脊椎系統 K231737ANAX™ 5.5 脊柱系統

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。