FDA 510(k)

DVR®橫鎖手腕擴展板（131849181）

K 號：K220244 · 2022-04-28

申請人Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

決定日期2022-04-28

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

DVR® Crosslock Wrist Spanning Plate (131849181) is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K220244. 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 DVR® Crosslock Wrist Spanning Plate (131849181)?

DVR® Crosslock Wrist Spanning Plate (131849181) is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. The 510(k) number is K220244.

When did DVR® Crosslock Wrist Spanning Plate (131849181) receive FDA 510(k) clearance?

DVR® Crosslock Wrist Spanning Plate (131849181) received FDA 510(k) clearance on 2022-04-28, under 510(k) number K220244.

Who is the listed applicant for DVR® Crosslock Wrist Spanning Plate (131849181)?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DVR® Crosslock Wrist Spanning Plate (131849181)?

The FDA product code for DVR® Crosslock Wrist Spanning Plate (131849181) is HRS.

其他以 Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech 為申請人之記錄

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K230993CODA™ 頸前板系統

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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