FDA 510(k)

4.0 and 6.5 Cancellous Bone Screw and Washer

K番号: K160946 · 2016-12-05

決定日2016-12-05

製品コードHWC

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

4.0 and 6.5 Cancellous Bone Screw and Washer is the device name listed in this FDA 510(k) record. The listed applicant is Smv Scientific. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K160946. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the 4.0 and 6.5 Cancellous Bone Screw and Washer?

4.0 and 6.5 Cancellous Bone Screw and Washer is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Smv Scientific. The 510(k) number is K160946.

When did 4.0 and 6.5 Cancellous Bone Screw and Washer receive FDA 510(k) clearance?

4.0 and 6.5 Cancellous Bone Screw and Washer received FDA 510(k) clearance on 2016-12-05, under 510(k) number K160946.

Who is the listed applicant for 4.0 and 6.5 Cancellous Bone Screw and Washer?

The FDA 510(k) record lists Smv Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4.0 and 6.5 Cancellous Bone Screw and Washer?

The FDA product code for 4.0 and 6.5 Cancellous Bone Screw and Washer is HWC. This falls under the Cardiovascular category.

申請者としてSmv Scientificを記載するその他の記録

K170021SMV科学的カニュライズドスクリュー K160603SMVサイエンティフィックシャンツ・スクリューズ

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