FDA 510(k)

APS 金屬板及螺釘系統

K 號：K223150 · 2023-08-24

決定日期2023-08-24

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

APS Metal Plate & Screw System 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 2023-08-24 under 510(k) number K223150. 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 Metal Plate & Screw System?

APS Metal Plate & Screw System is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is A Plus Biotechnology Co., Ltd.. The 510(k) number is K223150.

When did APS Metal Plate & Screw System receive FDA 510(k) clearance?

APS Metal Plate & Screw System received FDA 510(k) clearance on 2023-08-24, under 510(k) number K223150.

Who is the listed applicant for APS Metal Plate & Screw System?

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 Metal Plate & Screw System?

The FDA product code for APS Metal Plate & Screw System is HRS.

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。

K254053APS 鋒鎖定板 K252897APS 骨切骨固定系統 (0945-1302-xx / 4.5mm 皮質螺釘); APS 骨切骨固定系統 (0850-4302-xx / 5.0mm 鎖定螺釘); APS 骨切骨固定系統 (0701-xx10(1)-05 / 近端內側胫骨骨切骨鎖定板); APS 骨切骨固定系統 (0701-xx60(1)-0x / 近端內側胫骨骨切骨鎖定板，小型); APS 骨切骨固定系統 (0702-xx00(1)-03 / 近端外側胫骨骨切骨鎖定板); APS 骨切骨固定系統 (0501-xx00(1)-04 / 遠端)

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。

K261892ProRib固定系統Costa Surgical, Inc.K262098EnHAnce PEEK 趾骨隆起系統Nvision Biomedical Technologies K262963TMC 偽骨固定系統Treace Medical Concepts, Inc.K261647Tempo植板系統；超壓縮螺釘系統Pace Surgical K261830FRAXION 3.5 板系統（多種 - 見目錄）；FRAXION 4.5 板系統（多種 - 見目錄）；FRAXION Mini 板系統（多種 - 見目錄）；FRAXION 骨釘系統（多種 - 見目錄）Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock 無菌板片系統GM Dos Reis Industria e Comercio Ltda.

官方來源

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