FDA 510(k)

OsteoCentric 骨板及螺釘系統

K 號：K250494 · 2025-03-18

決定日期2025-03-18

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

The OsteoCentric Bone Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K250494. 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 The OsteoCentric Bone Plate and Screw System?

The OsteoCentric Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is OsteoCentric Technologies. The 510(k) number is K250494.

When did The OsteoCentric Bone Plate and Screw System receive FDA 510(k) clearance?

The OsteoCentric Bone Plate and Screw System received FDA 510(k) clearance on 2025-03-18, under 510(k) number K250494.

Who is the listed applicant for The OsteoCentric Bone Plate and Screw System?

The FDA 510(k) record lists OsteoCentric Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The OsteoCentric Bone Plate and Screw System?

The FDA product code for The OsteoCentric Bone Plate and Screw System is HRS.

其他以 OsteoCentric Technologies 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。

K251913OsteoCentric® UnifiMI® TCS 鋼板系統 K242691OsteoCentric Technologies 穿刺螺釘及螺母 K230242骨心齒植體系統 K230226Integrity-SI® 結合系統 K230595骨心臟前交叉韁綁固定系統 K230764骨心整合髋關節固定系統

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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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