FDA 510(k)

DVR®クロスロック・ウエスト・スパンニング・プレート（131849181）

K番号: K220244 · 2022-04-28

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

決定日2022-04-28

製品コードHRS

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてPioneer Surgical Technology, Inc D.B.A Resolve Surgical Techを記載するその他の記録

K230993CODA™前方頸椎プレートシステム

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