FDA 510(k)

PediFlex™ 強韌指甲系統

K 號：K251362 · 2025-06-24

決定日期2025-06-24

產品代碼HTY

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器材摘要

PediFlex™ Flexible Nail System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-06-24 under 510(k) number K251362. 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 PediFlex™ Flexible Nail System?

PediFlex™ Flexible Nail System is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K251362.

When did PediFlex™ Flexible Nail System receive FDA 510(k) clearance?

PediFlex™ Flexible Nail System received FDA 510(k) clearance on 2025-06-24, under 510(k) number K251362.

Who is the listed applicant for PediFlex™ Flexible Nail System?

FDA 510(k) 記錄將 OrthoPediatrics Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for PediFlex™ Flexible Nail System?

The FDA product code for PediFlex™ Flexible Nail System is HTY.

其他以 OrthoPediatrics Corp. 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。

K261345兒童釘針平台髋骨 K260323OrthoPediatrics® 鎖定中空刀片板系統 K252600兒童植板平台 I 小型-迷你 K243963兒童植板平台髋 K250623兒童釘針平台道骨兒童釘針平台股骨 K241816維特萊德脊椎成長引導系統

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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.K250646影響 PEEK 聯合釘系統Nvision Biomedical Technologies K241014比奧美特克irschner針（K針）Biomet, Inc.

官方來源

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