PBF
- 产品代码
- PBF
- 器械名称
- Orthopaedic Surgical Planning And Instrument Guides
- 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
- 该代码近三年的 510(k)
- 27 件
FDA 分类定义
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
该代码近三年的 510(k)（14 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K252064 | 2026-03-27 | Medcad | MedCAD® AccuStride System 摘要 |
| K250711 | 2025-12-05 | 3D Systems, Inc. | VSP Orthopedics System 摘要 |
| K242603 | 2025-11-19 | Medacta International S.A. | MyPAO SA guides 摘要 |
| K251709 | 2025-11-04 | Medcad | MedCAD® AccuStride System 摘要 |
| K250394 | 2025-10-21 | Bodycad Laboratories, Inc. | Fine TTO 摘要 |
| K250767 | 2025-10-01 | Newclip Technics | Newclip Patient-matched instrumentation non sterile 摘要 |
| K250921 | 2025-06-25 | Blue Belt Technologies, Inc. | CORIOGRAPH Pre-Op Planning and Modeling Services 摘要 |
| K241811 | 2025-03-13 | Medcad | MedCAD® AccuStride System 摘要 |
| K243912 | 2025-02-13 | Newclip Technics | Newclip Patient-matched instrumentation non sterile 摘要 |
| K240415 | 2024-11-07 | Newclip Technics | Newclip Patient-matched instrumentation non sterile 摘要 |
| K240113 | 2024-03-18 | Smith & Nephew, Inc. | CORIOGRAPH Knee Pre-Op Plan 摘要 |
| K240066 | 2024-02-09 | Bodycad Laboratories, Inc. | Fine Osteotomy 摘要 |
| K221615 | 2023-10-25 | Newclip Technics | Newclip Patient-matched instrumentation non sterile 摘要 |
| K223421 | 2023-09-20 | Medcad | MedCAD AccuPlan Orthopedics System 摘要 |
FDA 官方分类页： PBF
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。