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 |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE™;Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2026-09-11 |
| K260364 | Device 300419 Strip | Geistlich Pharma AG | 2026-06-02 |
| K252797 | JAZBI™ Resorbable Bone Void Filler | Sdip Innovations Pty, Ltd. | 2026-05-26 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199284455788 | BonVie+ | ELUTE , INC. | 2025-08-13 |
| 00085412678146 | ALTAPORE | Apatech Ltd | 2020-11-05 |
| 00085412630731 | ALTAPORE | Apatech Ltd | 2020-11-05 |
| 00085412654393 | ALTAPORE | Apatech Ltd | 2019-12-11 |
| 00085412654362 | ALTAPORE | Apatech Ltd | 2019-12-11 |
| 00085412654379 | ALTAPORE | Apatech Ltd | 2019-12-11 |
| 00085412654386 | ALTAPORE | Apatech Ltd | 2019-12-11 |
| 00613994247612 | PROGENIX® PUTTY and PROGENIX® PLUS | MEDTRONIC SOFAMOR DANEK, INC. | 2019-03-29 |
| 00613994512802 | MASTERGRAFT® Mini Granules | MEDTRONIC SOFAMOR DANEK, INC. | 2018-11-18 |
| 00613994512796 | MASTERGRAFT® Mini Granules | MEDTRONIC SOFAMOR DANEK, INC. | 2018-11-18 |
| 00613994512789 | MASTERGRAFT® Mini Granules | MEDTRONIC SOFAMOR DANEK, INC. | 2018-11-18 |
| 00613994512772 | MASTERGRAFT® Mini Granules | MEDTRONIC SOFAMOR DANEK, INC. | 2018-11-18 |
| 00613994512765 | MASTERGRAFT® Mini Granules | MEDTRONIC SOFAMOR DANEK, INC. | 2018-11-18 |
| 00613994512758 | MASTERGRAFT® Mini Granules | MEDTRONIC SOFAMOR DANEK, INC. | 2018-11-18 |
| 00813954021157 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021140 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021133 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021126 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021119 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021102 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021096 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021089 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021072 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00813954021065 | Augmatrix | COLLAGEN MATRIX, INC. | 2015-10-23 |
| 00613994236401 | PROGENIX® PUTTY and PROGENIX® PLUS | MEDTRONIC SOFAMOR DANEK, INC. | 2015-07-20 |
| 00613994236418 | PROGENIX® PUTTY and PROGENIX® PLUS | MEDTRONIC SOFAMOR DANEK, INC. | 2015-07-20 |
| 00613994236425 | PROGENIX® PUTTY and PROGENIX® PLUS | MEDTRONIC SOFAMOR DANEK, INC. | 2015-07-20 |
| 00613994407801 | MASTERGRAFT® STRIP | MEDTRONIC SOFAMOR DANEK, INC. | 2015-07-20 |
| 00613994407818 | MASTERGRAFT® STRIP | MEDTRONIC SOFAMOR DANEK, INC. | 2015-07-20 |
| 00613994487339 | MASTERGRAFT® STRIP | MEDTRONIC SOFAMOR DANEK, INC. | 2015-07-20 |