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AO ExpertTM Proximal Humeral Nail System (sterilization) / AO ExpertTM Humeral Nail System (sterilization) - PMDA ID 340216_21900BZX00770000_A_01_03

AO ExpertTM プロキシマルヒューメラルネイルシステム(滅菌)/AO ExpertTM ヒューメラルネイル システム(滅菌)

Access comprehensive regulatory information for AO ExpertTM Proximal Humeral Nail System (sterilization) / AO ExpertTM Humeral Nail System (sterilization) (AO ExpertTM プロキシマルヒューメラルネイルシステム(滅菌)/AO ExpertTM ヒューメラルネイル システム(滅菌)) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 340216_21900BZX00770000_A_01_03 and manufactured by Johnson & Johnson K.K.. The device information was last updated on July 05, 2022.

This page provides complete registration details including device class (B0400), classification (Upper extremity intramedullary nail for internal fixation / 体内固定用上肢髄内釘), 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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PMDA Official Data
Bilingual (EN/JP)
MD
B0400
340216_21900BZX00770000_A_01_03
MD
B0400
AO ExpertTM Proximal Humeral Nail System (sterilization) / AO ExpertTM Humeral Nail System (sterilization)
AO ExpertTM プロキシマルヒューメラルネイルシステム(滅菌)/AO ExpertTM ヒューメラルネイル システム(滅菌)
PMDA ID: 340216_21900BZX00770000_A_01_03
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Intended Use / 使用目的
English

-This product is a set of implants consisting of an intramedullary nail made of titanium alloy and its accessories for the purpose of fixing a proximal fracture in the humerus. i) ・This product is intended for fixation of diaphysis or diaphyseal end fractures in the humerus. ⅱ)

日本語 (Japanese)

・本品は、上腕骨における近位部骨折の固定を目的とする、チタン合金製の髄内釘及びその付属品からなるインプラント一式である。ⅰ)・本品は、上腕骨における骨幹部もしくは骨幹端部骨折の固定を目的とする。ⅱ)

Device Classification / 分類
Device Type
MD
Device Class
B0400
Class Name (English)
Upper extremity intramedullary nail for internal fixation
Class Name (日本語)
体内固定用上肢髄内釘
Registration Information / 登録情報
PMDA ID
340216_21900BZX00770000_A_01_03
Last Update Date
July 05, 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)
AO ExpertTM Proximal Humeral Nail System (sterilization) / AO ExpertTM Humeral Nail System (sterilization)
Market Name (日本語)
AO ExpertTM プロキシマルヒューメラルネイルシステム(滅菌)/AO ExpertTM ヒューメラルネイル システム(滅菌)