OBT

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

产品代码

OBT

器械名称

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 888.3030

FDA 专业组

Orthopedic

上市路径

需提交 510(k) 上市前通告

标记

属植入器械

标记

属生命支持/维持器械

该代码近三年的 510(k)

6 件

FDA 分类定义

Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。