FDA 510(k)

WishBone醫療板及螺釘系統

K 號：K230527 · 2023-03-29

決定日期2023-03-29

產品代碼HRS

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決定相當於

器材摘要

WishBone Medical Plate and Screw System 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 2023-03-29 under 510(k) number K230527. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WishBone Medical Plate and Screw System?

WishBone Medical Plate and Screw System is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K230527.

When did WishBone Medical Plate and Screw System receive FDA 510(k) clearance?

WishBone Medical Plate and Screw System received FDA 510(k) clearance on 2023-03-29, under 510(k) number K230527.

Who is the listed applicant for WishBone Medical Plate and Screw System?

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 WishBone Medical Plate and Screw System?

The FDA product code for WishBone Medical Plate and Screw System is HRS.

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。

K231461智慧校正系統（HA 半針）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：HRS）

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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