Pediatric Nailing Platform Femur
K 號：K261345 · 2026-09-24
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器材摘要
Pediatric Nailing Platform Femur is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K261345. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pediatric Nailing Platform Femur?
Pediatric Nailing Platform Femur is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K261345.
When did Pediatric Nailing Platform Femur receive FDA 510(k) clearance?
Pediatric Nailing Platform Femur received FDA 510(k) clearance on 2026-09-24, under 510(k) number K261345.
Who is the listed applicant for Pediatric Nailing Platform Femur?
The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pediatric Nailing Platform Femur?
The FDA product code for Pediatric Nailing Platform Femur is HSB.
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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。
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相關器械（代碼：HSB）
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。
K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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