MAI
- 产品代码
- MAI
- 器械名称
- Fastener, Fixation, Biodegradable, Soft Tissue
- 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
- 该代码近三年的 510(k)
- 221 件
该代码近三年的 510(k)（21 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262357 | 2026-08-07 | Arthrex, Inc. | Arthrex Bioabsorbable PushLock Suture Anchors 摘要 |
| K253931 | 2026-05-28 | Arthrex, Inc. | Arthrex Bioabsorbable PushLock Suture Anchors 摘要 |
| K260294 | 2026-03-27 | Surgical Fusion Technologies GmbH | SF Push-in Anchor 摘要 |
| K254055 | 2026-02-24 | OSSIO , Ltd. | OSSIOfiber® Suture Anchor 摘要 |
| K251680 | 2026-02-17 | Biocomposites, Ltd. | Biosteon® Screw 摘要 |
| K252946 | 2025-10-15 | Conmed Corporation | BioBrace® Extra-Articular Ligament Augmentation Kit 摘要 |
| K252022 | 2025-08-19 | OSSIO , Ltd. | OSSIOfiber® Interference Screw 摘要 |
| K251309 | 2025-05-27 | OSSIO , Ltd. | OSSIOfiber® Suture Anchor 摘要 |
| K250544 | 2025-05-23 | Stryker Endoscopy | Knotilus+ Biocomposite Knotless Anchor 摘要 |
| K250528 | 2025-05-21 | Stryker Endoscopy | Stryker AlphaVent Knotless SP Biocomposite Anchor 摘要 |
| K243760 | 2025-04-03 | OSSIO , Ltd. | OSSIOfiber® Suture Anchor 2.5-3.5 mm 摘要 |
| K250526 | 2025-03-14 | Arthrex, Inc. | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Sut 摘要 |
| K243790 | 2025-02-05 | Depuy Mitek | GRYPHON X Anchor; HEALIX TRANSTEND Anchor 摘要 |
| K243467 | 2024-12-03 | Osteonic Co., Ltd. | Fix2Lock (Biocomposite medial, Biocomposite lateral, 摘要 |
| K241010 | 2024-09-11 | Depuy Mitek | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self 摘要 |
| K241912 | 2024-07-29 | Nanofiber Solutions, LLC | BIOCHARGE 摘要 |
| K233971 | 2024-06-04 | Arthrex, Inc. | Arthrex AlloSync PushLock Suture Anchor 摘要 |
| K240288 | 2024-04-01 | Surgical Fusion Technologies GmbH | SF Push- in Anchor 摘要 |
| K240441 | 2024-03-15 | Depuy Mitek | MILAGRO Interference Screw; MILAGRO ADVANCE Interfer 摘要 |
| K240090 | 2024-03-05 | Conmed Corporation | Argo Knotless GENESYS Anchor 摘要 |
| K232513 | 2023-09-18 | Parcus Medical | X-Twist Biocomposite Suture Anchor 摘要 |
FDA 官方分类页： MAI
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。