FDA 510(k)

Amendia 獨立頸部系統

K 號：K152972 · 2016-01-14

決定日期2016-01-14

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Amendia Stand-Alone Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152972. 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 Amendia Stand-Alone Cervical System?

Amendia Stand-Alone Cervical System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Amendia, Inc.. The 510(k) number is K152972.

When did Amendia Stand-Alone Cervical System receive FDA 510(k) clearance?

Amendia Stand-Alone Cervical System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152972.

Who is the listed applicant for Amendia Stand-Alone Cervical System?

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

What is the FDA product code for Amendia Stand-Alone Cervical System?

The FDA product code for Amendia Stand-Alone Cervical System is OVE.

其他以 Amendia, 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。

K160924Amendia 間隙融合設備 K161842Overwatch脊椎系統 K152920Savannah-T®脊椎釘系統 K153152齊星穩定系統 K160291Optimus ALIF 系統 K151310Amendia 間隙融合設備

查看所有 7 項裝置 →

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。