ZipToe™ 間趾融合系統
K 號：K253325 · 2025-12-29
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器材摘要
ZipToe™ Hammertoe Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Toetal Solutions. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K253325. 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 ZipToe™ Hammertoe Fusion System?
ZipToe™ Hammertoe Fusion System is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Toetal Solutions. The 510(k) number is K253325.
When did ZipToe™ Hammertoe Fusion System receive FDA 510(k) clearance?
ZipToe™ Hammertoe Fusion System received FDA 510(k) clearance on 2025-12-29, under 510(k) number K253325.
Who is the listed applicant for ZipToe™ Hammertoe Fusion System?
The FDA 510(k) record lists Toetal Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZipToe™ Hammertoe Fusion System?
The FDA product code for ZipToe™ Hammertoe Fusion System is HTY.
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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。
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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