FDA 510(k)

アシロックチタニウム干渉スクリュー

K番号: K203029 · 2021-08-20

決定日2021-08-20

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

Auxilock Titanium Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K203029. 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 Auxilock Titanium Interference Screw?

Auxilock Titanium Interference Screw is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K203029.

When did Auxilock Titanium Interference Screw receive FDA 510(k) clearance?

Auxilock Titanium Interference Screw received FDA 510(k) clearance on 2021-08-20, under 510(k) number K203029.

Who is the listed applicant for Auxilock Titanium Interference Screw?

The FDA 510(k) record lists Auxein Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auxilock Titanium Interference Screw?

The FDA product code for Auxilock Titanium Interference Screw is HWC. This falls under the Cardiovascular category.

申請者としてAuxein Medical Private Limitedを記載するその他の記録

K221787オクシン社のDHS/DCSプレートシステム K213059チベリア・フィブラ・システム K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor K213018Auxilock GFSミニ、GFS IIラージ、およびGFSアンリミテッド K213108上腕骨・尺骨システム K213014Varixis肘関節システム

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