FDA 510(k)

OBS 防滑螺釘

K 號：K152297 · 2016-02-09

決定日期2016-02-09

產品代碼OAT

諮詢委員會DE

決定相當於

器材摘要

OBS Anchorage Screw is the device name listed in this FDA 510(k) record. The listed applicant is Bomei Co, Ltd.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K152297. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OBS Anchorage Screw?

OBS Anchorage Screw is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Bomei Co, Ltd.. The 510(k) number is K152297.

When did OBS Anchorage Screw receive FDA 510(k) clearance?

OBS Anchorage Screw received FDA 510(k) clearance on 2016-02-09, under 510(k) number K152297.

Who is the listed applicant for OBS Anchorage Screw?

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

What is the FDA product code for OBS Anchorage Screw?

The FDA product code for OBS Anchorage Screw is OAT.

其他以 Bomei 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。

K202278OBS固定位釘，Biokey固定位釘

相關器械（代碼：OAT）

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。

K260268OrthoEasy Pal；OrthoEasy Pal 長頸版Bernhard Förster GmbH (Bernhard Foerster Ltd.)K242944萊昂正畸植入物TAD（臨時固位裝置）Leone S.P.A.K231502迷你螺釘Proimtech Saglik Urunleri Anonim Sirketi K231913T-FITTechwin Co., Ltd.K222245ACR 螺釘系統Biomaterials Korea, Inc.K202163Mico One 正畸螺釘Ze Fang Technology Co., Ltd.

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。