BHR resurfacing system - PMDA ID 371113_22300BZX00020000_A_02_03
Access comprehensive regulatory information for BHR resurfacing system (BHR リサーフェシング 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 371113_22300BZX00020000_A_02_03 and manufactured by Smith & Nephew Co., Ltd.. The device information was last updated on July 25, 2022.
This page provides complete registration details including device class (B0400), classification (Resurfacing hip prosthesis / 表面置換型人工股関節), 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 an implant for joint function reconstruction used in orthopedics to replace only the surface of the bone head for the purpose of preserving the femoral head, and is used in combination with an implant on the acetabular side. Instead of using inserts on the sliding surface, joint movement is assisted by sliding by combining metal implants. Do not reuse because it is a disposable product. *Indicated patientsPlease be sure to refer to the O-P002A-003 instruction manual for non-inflammatory arthritis such as osteoarthritis, traumatic arthritis, oligohemonecrosis, etc.
本品は、整形外科において大腿骨頭を温存する目的で骨頭表面のみを置換するために用いる関節機能再建のためのインプラントであり、寛骨臼側のインプラントと組み合わせて使用する。摺動面にインサートを使用せず、金属製のインプラント同士を組み合わせて摺動させることで関節動を補助する。ディスポーザブル製品であるため再使用しない。*適応患者変形性関節症、外傷性関節炎、乏血壊死等の非炎症性関節炎（変形性関節疾患）等O-P002a-003取扱説明書を必ずご参照ください