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VELYS Robotic Assisted Solution - PMDA ID 340216_30400BZX00106000_A_01_01

VELYS ロボット支援ソリューション

Access comprehensive regulatory information for VELYS Robotic Assisted Solution (VELYS ロボット支援ソリューション) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 340216_30400BZX00106000_A_01_01 and manufactured by Johnson & Johnson K.K.. The device information was last updated on August 09, 2022.

This page provides complete registration details including device class (A1200), classification (surgical robotic surgery unit / 手術用ロボット手術ユニット), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.

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MD
A1200
340216_30400BZX00106000_A_01_01
MD
A1200
VELYS Robotic Assisted Solution
VELYS ロボット支援ソリューション
PMDA ID: 340216_30400BZX00106000_A_01_01
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Intended Use / 使用目的
English

It is a device for stereotactic surgery that identifies the position and direction, plans the implantation position of the femoral implant and tibial implant during surgery, and supports bone resection. This product is used for the ATTUNE total knee arthroplasty system and indicated cases of the system.

日本語 (Japanese)

的な位置と方向を特定し、術中に大腿骨インプラント及び脛骨インプラントの埋植位置を計画し、骨切除を支援する定位手術用の装置である。本品は、ATTUNE人工膝関節全置換術システム及び当該システムの適応症例に使用される。

Device Classification / 分類
Device Type
MD
Device Class
A1200
Class Name (English)
surgical robotic surgery unit
Class Name (日本語)
手術用ロボット手術ユニット
Registration Information / 登録情報
PMDA ID
340216_30400BZX00106000_A_01_01
Last Update Date
August 09, 2022
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/ジョンソン・エンド・ジョンソン株式会社
Product Names / 製品名
Market Name (English)
VELYS Robotic Assisted Solution
Market Name (日本語)
VELYS ロボット支援ソリューション