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)

SDS成長桿

K 號:K251961 · 2026-01-15

決定日期2026-01-15
產品代碼PGM
諮詢委員會或
決定相當於

器材摘要

SDS Growing Rod is the device name listed in this FDA 510(k) record. The listed applicant is BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K251961. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SDS Growing Rod?

SDS Growing Rod is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is BAAT Medical Products B.V.. The 510(k) number is K251961.

When did SDS Growing Rod receive FDA 510(k) clearance?

SDS Growing Rod received FDA 510(k) clearance on 2026-01-15, under 510(k) number K251961.

Who is the listed applicant for SDS Growing Rod?

The FDA 510(k) record lists BAAT Medical Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDS Growing Rod?

The FDA product code for SDS Growing Rod is PGM.

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。

其他以 BAAT Medical Products B.V. 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。

相關器械(代碼:PGM)

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。

↑