OQH
- 产品代码
- OQH
- 器械名称
- Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3350
- 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
FDA 分类定义
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
FDA 官方分类页： OQH
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。