MQV
- 产品代码
- MQV
- 器械名称
- Filler, Bone Void, Calcium Compound
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3045
- 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)
- 492 件
该代码近三年的 510(k)（55 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260364 | 2026-06-02 | Geistlich Pharma AG | Device 300419 Strip 摘要 |
| K252797 | 2026-05-26 | Sdip Innovations Pty, Ltd. | JAZBI Resorbable Bone Void Filler 摘要 |
| K261008 | 2026-04-24 | Stryker Spine | Vitoss® BiModal Bioactive Bone Graft Substitute Foam 摘要 |
| K253524 | 2026-02-17 | Biomendex OY | Adaptos®Fuse Bone Graft 摘要 |
| K253147 | 2025-10-22 | Prosidyan, Inc. | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBER 摘要 |
| K251522 | 2025-10-13 | Bone Solutions, Inc. | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE 摘要 |
| K252085 | 2025-09-30 | Wright Medical Technology, Inc. (Stryk | Allomatrix (Allomatrix Injectable Putty; Allomatrix 摘要 |
| K251556 | 2025-07-17 | Geistlich Pharma AG | Device 300423 Granules 摘要 |
| K251720 | 2025-07-02 | SurGenTec, LLC | OsteoFlo HydroFiber 摘要 |
| K251193 | 2025-06-12 | Medtronic Sofamor Danek, Inc. | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bo 摘要 |
| K243949 | 2025-05-28 | SurGenTec, LLC | OsteoFlo HydroFiber 摘要 |
| K243474 | 2025-05-23 | Kuros Biosciences B.V | MagnetOs MIS 摘要 |
| K250141 | 2025-05-16 | Austin Medical Ventures, Inc. | Synthecure Synthetic Calcium Sulfate 摘要 |
| K250521 | 2025-04-07 | Biocomposites, Ltd. | NanoBone® SBX Putty ; NanoBone® QD 摘要 |
| K250556 | 2025-03-21 | Ventris Medical | Porous Biologic Scaffold 摘要 |
| K250346 | 2025-02-26 | Elute, Inc. | BonVie+ 摘要 |
| K241555 | 2025-02-21 | Rti Surgical, Inc. | Moldable Bone Void Filler and Moldable Bone Void Fil 摘要 |
| K243706 | 2025-01-17 | Medtronic Sofamor Danek, Inc. | Mastergraft Matrix EXT; Mastergraft Strip; Mastergra 摘要 |
| K242797 | 2024-12-23 | SurGenTec, LLC | OsteoFlo HydroFiber 摘要 |
| K242782 | 2024-12-23 | Noraker | GlassBone Granules 摘要 |
| K241167 | 2024-12-20 | Synergy Biomedical | BioSphere Putty; BioSphere MIS Putty 摘要 |
| K243609 | 2024-12-18 | Etex Corporation | EquivaBone Osteoinductive Bone Graft Substitute (Equ 摘要 |
| K240765 | 2024-12-18 | Ventris Medical | Porous Biologic Scaffold 摘要 |
| K243526 | 2024-12-05 | Orthocon, Inc. | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS 摘要 |
| K243506 | 2024-11-18 | Orthocon, Inc. | Montage-XT Settable Bone Putty 摘要 |
| K241802 | 2024-11-08 | Geistlich Pharma AG | Device 300397 Putty 摘要 |
| K240450 | 2024-11-06 | Acuitive Technologies, Inc. | Citrepore 摘要 |
| K242372 | 2024-10-18 | Bone Solutions, Inc. | Mg OSTEOREVIVE, Mg OSTEOCRETE 摘要 |
| K242299 | 2024-09-25 | Novabone Products, LLC | NovaBone Putty - Synthetic Bioactive Bone Graft 摘要 |
| K242273 | 2024-09-25 | SeaSpine Orthopedics Corporation | Cove Putty, OsteoCove Putty 摘要 |
| K242280 | 2024-08-29 | Stryker Spine | Vitoss® BiModal Bioactive Bone Graft Substitute Foam 摘要 |
| K233566 | 2024-08-21 | Orthocon, Inc. | Montage-XT Settable, Resorbable Bone Putty 摘要 |
| K241564 | 2024-08-02 | Baxter Healthcare Corporation | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE 摘要 |
| K242050 | 2024-07-29 | Orthocon, Inc. | Montage Settable Bone Putty 摘要 |
| K241212 | 2024-06-27 | Kuros Biosciences | MagnetOs Easypack Putty 摘要 |
| K233259 | 2024-06-21 | Xerothera, Inc. | Xerosyn 摘要 |
| K240621 | 2024-04-30 | Biogennix, LLC | Morpheus® Moldable; Agilon® Moldable 摘要 |
| K240442 | 2024-04-01 | Kuros Biosciences B.V | MagnetOs Putty 摘要 |
| K240507 | 2024-03-20 | Nuvasive, Inc. | NuVasive AttraX Scaffold 摘要 |
| K240424 | 2024-03-12 | Collagen Matrix, Inc. | Mineral Collagen Composite Bioactive Moldable Bone G 摘要 |
| K240458 | 2024-03-07 | Ventris Medical | Synthetic Bone Putty 摘要 |
| K240404 | 2024-03-05 | Novabone Products, LLC | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6 摘要 |
| K240459 | 2024-03-05 | Bonesupport AB | Cerament Bone Void Filler 摘要 |
| K240453 | 2024-03-04 | Orthorebirth Co., Ltd. | ReBOSSIS 摘要 |
| K234013 | 2024-02-05 | Bone Solutions, Inc. | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE 摘要 |
| K232347 | 2024-01-19 | Kuros Biosciences B.V | MagnetOs Granules 摘要 |
| K230736 | 2023-12-20 | Kuros Biosciences B.V | MagnetOs Putty 摘要 |
| K231968 | 2023-12-20 | Anika Therapeutics, Inc. | Tactoset® Injectable Bone Substitute 摘要 |
| K233607 | 2023-12-15 | Kuros Biosciences B.V | MagnetOs Easypack Putty 摘要 |
| K233490 | 2023-12-05 | Bioventus, LLC | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty 摘要 |
| K233245 | 2023-11-21 | Kuros Biosciences B.V | MagnetOs Flex Matrix 摘要 |
| K231716 | 2023-10-02 | SurGenTec, LLC | OsteoFlo® HydroPutty 摘要 |
| K232668 | 2023-09-27 | SeaSpine Orthopedics Corporation | Cove Strip, OsteoCove Strip 摘要 |
| K232315 | 2023-09-15 | Ossdsign AB | Catalyst Bone Void Filler 摘要 |
| K231030 | 2023-09-14 | SeaSpine Orthopedics Corporation | Cove Putty, OsteoCove Putty 摘要 |
FDA 官方分类页： MQV
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。