FDA 510(k)

影響 PEEK 聯合釘系統

K 號：K250646 · 2025-06-11

決定日期2025-06-11

產品代碼HTY

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決定相當於

器材摘要

Impact PEEK Union Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2025-06-11 under 510(k) number K250646. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Impact PEEK Union Nail System?

Impact PEEK Union Nail System is a medical device that received FDA 510(k) clearance on 2025-06-11. The listed applicant is Nvision Biomedical Technologies. The 510(k) number is K250646.

When did Impact PEEK Union Nail System receive FDA 510(k) clearance?

Impact PEEK Union Nail System received FDA 510(k) clearance on 2025-06-11, under 510(k) number K250646.

Who is the listed applicant for Impact PEEK Union Nail System?

FDA 510(k) 記錄將 Nvision Biomedical Technologies 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Impact PEEK Union Nail System?

The FDA product code for Impact PEEK Union Nail System is HTY.

其他以 Nvision Biomedical 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。

K262098EnHAnce PEEK 趾骨隆起系統 K242896Caliber 髓內固定系統 K243231三角PEEK HA楔子 K234116Trigon Trigon HA 独立楔形固定系統

相關器械（代碼：HTY）

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。

K262722原始K釘（P99-193-1410）Paragon 28, Inc.K253325ZipToe™ 間趾融合系統Toetal Solutions K252657影響 PEEK 聯合釘系統Nvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ 強韌指甲系統OrthoPediatrics Corp.K241014比奧美特克irschner針（K針）Biomet, Inc.

官方來源

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