Japan PMDA registration 340772_22600BZX00450000_A_01_05

iASSISTKnee system

JP: iASSISTKneeシステム
Japan flagJapan·MD·A1200·Updated October 17, 2022
Intended use / 使用目的
English
This product is a device that provides position information of surgical instruments to the surgeon in knee joint replacement.
日本語 (Japanese)
本品は人工膝関節置換術において、手術用器具の位置情報を術者に提供する装置である。
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_22600BZX00450000_A_01_05
Last Update Date
October 17, 2022
Official Documents
View PDF (PMDA)
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
About this record

Access comprehensive regulatory information for iASSISTKnee system (iASSISTKnee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_22600BZX00450000_A_01_05 and manufactured by Manufacture and sales/Zimmer Biomet LLC. The device information was last updated on October 17, 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.

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