FDA 510(k)

智慧校正系統（HA 半針）

K 號：K231461 · 2023-06-16

決定日期2023-06-16

產品代碼KTT

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決定相當於

器材摘要

Smart Correction System (HA Half Pins) is the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K231461. 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 Smart Correction System (HA Half Pins)?

Smart Correction System (HA Half Pins) is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K231461.

When did Smart Correction System (HA Half Pins) receive FDA 510(k) clearance?

Smart Correction System (HA Half Pins) received FDA 510(k) clearance on 2023-06-16, under 510(k) number K231461.

Who is the listed applicant for Smart Correction System (HA Half Pins)?

The FDA 510(k) record lists Wishbone Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Correction System (HA Half Pins)?

The FDA product code for Smart Correction System (HA Half Pins) is KTT.

其他以 Wishbone Medical, Inc. 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。

K230527WishBone醫療板及螺釘系統 K221366智能校正系統環及相容的HA塗層半釘 K213489Wishbone醫療板及螺釘系統：3.0mm螺釘及7孔直型腓骨板 K203467WishBone醫療板及螺釘系統 K193368智慧校正系統 K180736WishBone醫療板及螺釘系統

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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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官方來源

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