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FDA 510(k)

智能校正系統環及相容的HA塗層半釘

K 號：K221366 · 2022-06-06

申請人Wishbone Medical, Inc.
決定日期2022-06-06
產品代碼KTT
諮詢委員會或
決定相當於

器材摘要

Smart Correction System Rings and Compatible HA-Coated 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 2022-06-06 under 510(k) number K221366. 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 Rings and Compatible HA-Coated Half Pins?

Smart Correction System Rings and Compatible HA-Coated Half Pins is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K221366.

When did Smart Correction System Rings and Compatible HA-Coated Half Pins receive FDA 510(k) clearance?

Smart Correction System Rings and Compatible HA-Coated Half Pins received FDA 510(k) clearance on 2022-06-06, under 510(k) number K221366.

Who is the listed applicant for Smart Correction System Rings and Compatible HA-Coated 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 Rings and Compatible HA-Coated Half Pins?

The FDA product code for Smart Correction System Rings and Compatible HA-Coated Half Pins is KTT.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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）K230527WishBone醫療板及螺釘系統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

查看所有 8 項裝置 →

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。

K254087MAXFRAME AUTOSTRUT™ 內建藍牙多軸校正系統Synthes (USA) Products, LLCK260900DYNEX® 外固定系統Vilex, LLCK260112QuikFix 外固定器：膝蓋跨包Stabiliz Orthopaedics, Inc.K253291優越系統Blue Ocean GlobalK253202霍夫曼LRF系統Stryker GmbHK253613猴環外環固定系統Paragon 28, Inc.

官方來源

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