FDA 510(k)

Wishbone醫療板及螺釘系統：3.0mm螺釘及7孔直型腓骨板

K 號：K213489 · 2022-01-27

決定日期2022-01-27

產品代碼HRS

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決定相當於

器材摘要

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate 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 2022-01-27 under 510(k) number K213489. 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: 3.0mm Screws and 7-Hole Straight Fibula Plate?

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K213489.

When did Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate receive FDA 510(k) clearance?

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate received FDA 510(k) clearance on 2022-01-27, under 510(k) number K213489.

Who is the listed applicant for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate?

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: 3.0mm Screws and 7-Hole Straight Fibula Plate?

The FDA product code for Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate is HRS.

其他以 Wishbone Medical, Inc. 為申請人之記錄

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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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