Standard No.:	YY/T 1502-2016
English Name:	Spinal implants―Intervertebral body fusion devices
Chinese Name:	脊柱植入物椎间融合器
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2016-07-29
Implemented on:	2017-6-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	130.0
Delivery:	via email in 1~3 business day

本标准规定了椎间融合器的术语、定义、预期性能、设计属性、材料、临床前评价、制造、灭菌和包装要求等。本标准适用于由金属和聚合物材料制造的椎间融合器，将其放置在相邻椎体间椎间盘位置，为两个椎体的融合提供支持。本标准不适用于药械组合产品（如：使用骨形态蛋白的椎间融合器）。