QHE
- 产品代码
- QHE
- 器械名称
- Shoulder Arthroplasty Implantation System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3660
- 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)
- 26 件
FDA 分类定义
Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
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 | 摘要 |
|---|---|---|---|---|
| K260802 | 2026-06-09 | Materialise NV | Materialise Shoulder System, Materialise Shoulder G | |
| K261510 | 2026-06-04 | Orthosoft Inc. (d/b/a) Zimmer CAS | Signature ONE System | |
| K260104 | 2026-02-04 | Orthosoft Inc. (d/b/a) Zimmer CAS | Signature ONE System | |
| K251558 | 2026-01-12 | Precision AI Pty, Ltd. | Precision AI Surgical Planning System (PAI-SPS) | |
| K243509 | 2025-05-12 | 3D-Side | Archer PSI System | |
| K241470 | 2025-02-20 | LinkBio Corp. | CORE Shoulder System | |
| K243955 | 2025-01-21 | Precision AI Pty, Ltd. | Precision AI Surgical Planning System (PAI-SPS) | |
| K242813 | 2024-10-18 | Materialise NV | Materialise Shoulder System, Materialise Shoulder G | FDA |
| K241097 | 2024-10-02 | Arthrex, Inc. | Arthrex Virtual Implant Positioning (VIP) System Sof | |
| K233992 | 2024-08-05 | Precision AI Pty, Ltd. | Precision AI Surgical Planning System (PAI-SPS) | |
| K241143 | 2024-05-22 | Materialise NV | Materialise Shoulder System, Materialise Shoulder G | |
| K232425 | 2023-12-12 | Orthosoft Inc. (D/B/A) Zimmer Cas) | Signature ONE System | |
| K233408 | 2023-11-09 | Materialise NV | Materialise Shoulder System, Materialise Shoulder G | |
| K231112 | 2023-09-12 | Materialise NV | Materialise Shoulder System, Materialise Shoulder G |
FDA 官方分类页： QHE
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。