APS 鋒鎖定板
K 號：K254053 · 2026-03-17
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器材摘要
APS Spear Locking Plate is the device name listed in this FDA 510(k) record. The listed applicant is A Plus Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K254053. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the APS Spear Locking Plate?
APS Spear Locking Plate is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is A Plus Biotechnology Co., Ltd.. The 510(k) number is K254053.
When did APS Spear Locking Plate receive FDA 510(k) clearance?
APS Spear Locking Plate received FDA 510(k) clearance on 2026-03-17, under 510(k) number K254053.
Who is the listed applicant for APS Spear Locking Plate?
The FDA 510(k) record lists A Plus Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for APS Spear Locking Plate?
The FDA product code for APS Spear Locking Plate is HRS.
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 A Plus Biotechnology 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。
相關器械（代碼：HRS）
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。
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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。
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