FDA 510(k)

CONFIDENCE™ 高粘度脊椎接着剤、VIPER®およびEXPEDIUM® 穿通スクリューシステム

K番号: K160879 · 2016-12-20

決定日2016-12-20

製品コードPML

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

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medos International Sàrl. It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K160879. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Medos International Sàrl. The 510(k) number is K160879.

When did CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems receive FDA 510(k) clearance?

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems received FDA 510(k) clearance on 2016-12-20, under 510(k) number K160879.

Who is the listed applicant for CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

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

What is the FDA product code for CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

The FDA product code for CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is PML.

申請者としてMedos International Sàrlを記載するその他の記録

K231527トリアルティスナビゲーションエンアビリティドインストルメント K223688CONDUIT™ 横方向腰椎間盤融合カage、CONDUIT™ 機器 K200245EXPEDIUM®脊椎システム；EXPEDIUM VERSE®脊椎システム

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