Pure Global

ROSARecon robot system - PMDA ID 340772_30200BZX00203000_A_01_04

ROSAReconロボットシステム

Access comprehensive regulatory information for ROSARecon robot system (ROSAReconロボットシステム) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 340772_30200BZX00203000_A_01_04 and manufactured by Manufacture and sales/Zimmer Biomet LLC. The device information was last updated on October 03, 2022.

This page provides complete registration details including device class (A1200), classification (surgical navigation unit / 手術用ナビゲーションユニット), 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.

Free Database
Powered by Pure Global AI
PMDA Official Data
Bilingual (EN/JP)
MD
A1200
340772_30200BZX00203000_A_01_04
MD
A1200
ROSARecon robot system
ROSAReconロボットシステム
PMDA ID: 340772_30200BZX00203000_A_01_04
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use / 使用目的
English

In knee replacement surgery (TKA), the evaluation of the soft tissue of the knee joint is displayed on the screen by optically measuring surgical instruments and the patient's position information, etc. during surgery, and the robotic arm transports the instrument to the optimal osteotomy position for implant installation based on intraoperative planning.

日本語 (Japanese)

本品は、人工膝関節置換術(TKA)において、術中に手術器具及び患者の位置情報等を光学的に計測することで、膝関節の軟部組織の評価を画面に表示し、ロボットアームが術中プランニングに基づいたインプラント設置のための最適な骨切除の位置に器具を運搬することで、TKA手術を支援する装置である。

Device Classification / 分類
Device Type
MD
Device Class
A1200
Class Name (English)
surgical navigation unit
Class Name (日本語)
手術用ナビゲーションユニット
Registration Information / 登録情報
PMDA ID
340772_30200BZX00203000_A_01_04
Last Update Date
October 03, 2022
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/ジンマー・バイオメット合同会社
Product Names / 製品名
Market Name (English)
ROSARecon robot system
Market Name (日本語)
ROSAReconロボットシステム