FDA 510(k)

回應正骨科智慧固定器 - 六足系統

K 號：K252625 · 2025-11-20

決定日期2025-11-20

產品代碼KTT

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器材摘要

The Response Ortho Smart Fixator - Hexapod System is the device name listed in this FDA 510(k) record. The listed applicant is Response Ortho Solutions, LLC. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K252625. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Response Ortho Smart Fixator - Hexapod System?

The Response Ortho Smart Fixator - Hexapod System is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Response Ortho Solutions, LLC. The 510(k) number is K252625.

When did The Response Ortho Smart Fixator - Hexapod System receive FDA 510(k) clearance?

The Response Ortho Smart Fixator - Hexapod System received FDA 510(k) clearance on 2025-11-20, under 510(k) number K252625.

Who is the listed applicant for The Response Ortho Smart Fixator - Hexapod System?

The FDA 510(k) record lists Response Ortho Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Response Ortho Smart Fixator - Hexapod System?

The FDA product code for The Response Ortho Smart Fixator - Hexapod System is KTT.

其他以 Response Ortho Solutions, LLC 為申請人之記錄

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K241769正骨科 metaphyseal 擴接器系統

相關器械（代碼：KTT）

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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