FDA 510(k)

Exalta 近端胫骨板系統

K 號：K261207 · 2026-06-12

決定日期2026-06-12

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Exalta Proximal Tibia Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K261207. 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 Exalta Proximal Tibia Plating System?

Exalta Proximal Tibia Plating System is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Tyber Medical, LLC. The 510(k) number is K261207.

When did Exalta Proximal Tibia Plating System receive FDA 510(k) clearance?

Exalta Proximal Tibia Plating System received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261207.

Who is the listed applicant for Exalta Proximal Tibia Plating System?

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

What is the FDA product code for Exalta Proximal Tibia Plating System?

The FDA product code for Exalta Proximal Tibia Plating System is HRS.

其他以 Tyber Medical, LLC 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。

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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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