Product code MQV
- Device name
- Filler, Bone Void, Calcium Compound
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3045
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graf... | Stryker Spine | 2026-04-24 |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | 2026-02-17 |
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2025-10-22 |
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2025-10-13 |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-09-30 |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | 2025-07-17 |
| K251720 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025-07-02 |
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | Medtronic Sofamor Danek, Inc. | 2025-06-12 |
| K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025-05-28 |
| K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025-05-23 |
| K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | 2025-05-16 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | 2025-04-07 |
| K250556 | Porous Biologic Scaffold | Ventris Medical | 2025-03-21 |
| K250346 | BonVie+ | Elute, Inc. | 2025-02-26 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | 2025-02-21 |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. | 2025-01-17 |
| K242782 | GlassBone Granules | Noraker | 2024-12-23 |
| K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024-12-23 |
| K241167 | BioSphere Putty; BioSphere MIS Putty | Synergy Biomedical | 2024-12-20 |
| K240765 | Porous Biologic Scaffold | Ventris Medical | 2024-12-18 |
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | Etex Corporation | 2024-12-18 |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2024-12-05 |
| K243506 | Montage-XT Settable Bone Putty | Orthocon, Inc. | 2024-11-18 |
| K241802 | Device 300397 Putty | Geistlich Pharma AG | 2024-11-08 |
| K240450 | Citrepore™ | Acuitive Technologies, Inc. | 2024-11-06 |
| K242372 | Mg OSTEOREVIVE™, Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2024-10-18 |
| K242273 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | 2024-09-25 |
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | Novabone Products, LLC | 2024-09-25 |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Subs... | Stryker Spine | 2024-08-29 |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. | 2024-08-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03760191133730 | GlassBone Granules | NORAKER | 2026-05-27 |
| 03760191134942 | MectaBlast Granules | NORAKER | 2026-05-27 |
| 03760191134935 | MectaBlast Granules | NORAKER | 2026-05-27 |
| 03760191134928 | MectaBlast Granules | NORAKER | 2026-05-27 |
| 03760191134911 | MectaBlast Granules | NORAKER | 2026-05-27 |
| 03760191134904 | MectaBlast Granules | NORAKER | 2026-05-27 |
| 03760191134898 | MectaBlast Granules | NORAKER | 2026-05-27 |
| 03760191134881 | MectaBlast Granules | NORAKER | 2026-05-27 |
| 03760191134874 | AktiBone Granules | NORAKER | 2026-05-27 |
| 03760191134867 | AktiBone Granules | NORAKER | 2026-05-27 |
| 03760191134850 | AktiBone Granules | NORAKER | 2026-05-27 |
| 03760191134836 | AktiBone Granules | NORAKER | 2026-05-27 |
| 03760191133723 | GlassBone Granules | NORAKER | 2026-05-27 |
| 03760191133747 | GlassBone Granules | NORAKER | 2026-05-27 |
| 03760191133754 | GlassBone Granules | NORAKER | 2026-05-27 |
| 03760191133761 | GlassBone Granules | NORAKER | 2026-05-27 |
| 03760191133778 | GlassBone Granules | NORAKER | 2026-05-27 |
| 03760191133785 | GlassBone Granules | NORAKER | 2026-05-27 |
| 03760191134812 | AktiBone Granules | NORAKER | 2026-05-27 |
| 03760191134829 | AktiBone Granules | NORAKER | 2026-05-27 |
| 03760191134843 | AktiBone Granules | NORAKER | 2026-05-27 |
| 07613327176957 | NA | Stryker Corporation | 2015-10-24 |
| 07613327176964 | NA | Stryker Corporation | 2015-10-24 |
| 07613327176995 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177046 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177053 | NA | Stryker Corporation | 2015-10-24 |
| 07613327177381 | BIO DBM | Stryker Corporation | 2015-10-24 |
| 07613327177398 | BIO DBM | Stryker Corporation | 2015-10-24 |
| 07613327177404 | BIO DBM | Stryker Corporation | 2015-10-24 |
| 07613327177428 | BIO DBM | Stryker Corporation | 2015-10-24 |