ABC cervical anterior fixation plate system - PMDA ID 170163_21400BZY00414000_A_01_02
Access comprehensive regulatory information for ABC cervical anterior fixation plate system (ABC頚椎前方固定用プレートシステム) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 170163_21400BZY00414000_A_01_02 and manufactured by Manufacture and sales / B.Brown Ace scrap Co., Ltd.. The device information was last updated on December 14, 2021.
This page provides complete registration details including device class (B0400), classification (spinal fixation device / 脊椎内固定器具), 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.
This product is used as an internal fixator to assist in the normal healing process in the treatment of cervical instability such as degenerative diseases of the vertebral body, post-traumatic instability, and tumors. It is not replaced with a normal bone structure, nor is it permanently burdened if healing is not successful, but is removed after bone fusion has been obtained. 2. Performance (indications)When treating the following symptoms, stabilize the single and double vertebral bodies for the purpose of fusion of the anterior cervical spine. ・Unstable state due to degeneration (degenerative disease of the vertebral body), unstable state after trauma, degenerative disease and instability of the tumor vertebral body refer to the following symptoms. Decrease in intervertebral disc thickness, crosslinking of the terminal vertebral plate, osteophyte formation, and / or scarring or thickening of ligament structure 3. Efficacy or Effect By installing and fixing an implant in the affected area of the cervical spine, the affected area is stabilized and the normal bone fusion process is assisted.
本品は、椎体の変性疾患、外傷後の不安定性、腫瘍等の頚椎不安定性の治療において、正常な治癒の過程を補助するための内固定具として使用する。正常な骨構造に置換するもの、また治癒が成功しない場合に負荷を永久的に負うものではなく、骨癒合が得られた後は抜去されるものである。2. 性能（適応症）下記の症状を治療する際に、前方頚椎の癒合を目的として単椎体及び複椎体を安定させる。・変性による不安定な状態（椎体の変性疾患）・外傷後の不安定な状態・腫瘍椎体の変性疾患や不安定性とは次の症状を指す。・椎間板の厚みの減少・椎体終板の架橋・骨棘形成及び/又は靭帯構造の瘢痕化又は肥厚3. 効能又は効果頚椎患部にインプラントを設置し固定することで患部の安定化を図り、正常な骨癒合過程を補助する。