免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

OsteoSync™ Ti 齒科網絡

K 號:K202918 · 2021-07-14

決定日期2021-07-14
產品代碼JEY
諮詢委員會DE
決定相當於

器材摘要

OsteoSync™ Ti Dental Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sites Medical, LLC. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K202918. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoSync™ Ti Dental Mesh?

OsteoSync™ Ti Dental Mesh is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Sites Medical, LLC. The 510(k) number is K202918.

When did OsteoSync™ Ti Dental Mesh receive FDA 510(k) clearance?

OsteoSync™ Ti Dental Mesh received FDA 510(k) clearance on 2021-07-14, under 510(k) number K202918.

Who is the listed applicant for OsteoSync™ Ti Dental Mesh?

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

What is the FDA product code for OsteoSync™ Ti Dental Mesh?

The FDA product code for OsteoSync™ Ti Dental Mesh is JEY.

相關臨床試驗

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。

相關器械(代碼:JEY)

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。

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。

↑