Absorbable craniomaxillofacial plate system - NMPA Registration 国械注准20243131809
Access comprehensive regulatory information for Absorbable craniomaxillofacial plate system in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243131809 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on September 19, 2024.
This page provides complete registration details including registrant information, province location (Tianjin), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
Suitable for internal fixation of craniomaxillofacial fractures.
适用于颅颌面骨折内固定。
The resorbable craniomaxillofacial plate system consists of an absorbable plate and an absorbable bone screw. Resorbable plates include straight plates, arc plates, X-shaped plates, L-shaped left curved plates, L-shaped right-curved plates, H-shaped plates, reticular plates, triangular plates, orbital floor plate I., orbital floor plate type II., orbital floor plate type III, orbital floor plate IV., orbital floor plate V. type. The resorbable craniomaxillofacial plate system is a blend of two copolymers, one (L-lactate-D, L-lactic acid) copolymer with the material grade PLDL 1002 and the other (L-lactate-trimethylene carbonate) copolymer with the material grade PLTMC4003. The product is supplied sterile after irradiation sterilization, and the sterilization validity period is 3 years, and it is used once.
可吸收颅颌面接骨板系统由可吸收接骨板和可吸收接骨螺钉组成。可吸收接骨板包括直形接骨板、弧形接骨板、X形接骨板、L形左弯接骨板、L形右弯接骨板、H形接骨板、网状接骨板、三角板、眶底板Ⅰ型、眶底板Ⅱ型、眶底板Ⅲ型、眶底板Ⅳ型、眶底板Ⅴ型。可吸收颅颌面接骨板系统由两种共聚物共混制成，一种共聚物为（L-乳酸-D，L乳酸）共聚物，材料牌号为PLDL 1002；另一种为（L-乳酸-三亚甲基碳酸酯）共聚物，材料牌号为PLTMC4003。产品经辐照灭菌后以无菌状态供货，灭菌有效期为3年，一次性使用。