FDA 510(k)

提升PEEK趾骨系統

K 號：K253718 · 2026-04-01

申請人Nvision Biomedical Technologies, Inc.

決定日期2026-04-01

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

enHAnce PEEK Bunion System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K253718. 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 enHAnce PEEK Bunion System?

enHAnce PEEK Bunion System is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K253718.

When did enHAnce PEEK Bunion System receive FDA 510(k) clearance?

enHAnce PEEK Bunion System received FDA 510(k) clearance on 2026-04-01, under 510(k) number K253718.

Who is the listed applicant for enHAnce PEEK Bunion System?

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

What is the FDA product code for enHAnce PEEK Bunion System?

The FDA product code for enHAnce PEEK Bunion System is HRS.

其他以 Nvision Biomedical Technologies, Inc. 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。

K260291Vortex5 尖鈎趾修復系統 K253423ToeJack MIS Bunion System K252657影響 PEEK 聯合釘系統 K250613SnapHammer 間趾調整系統 K2402503D打印PEEK間置系統 K231453SnapHammer 間趾調整系統

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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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