510(k) K242299
- Device
- NovaBone Putty - Synthetic Bioactive Bone Graft
- Applicant
- Novabone Products, LLC
- 510(k) number
- K242299
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-25
- Date received
- 2024-08-02
- Regulation
- 888.3045
- Classification name
- Filler, Bone Void, Calcium Compound
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Ed Horton
- Address
- 13510 NW Us Hwy. 441 Alachua FL US 32615 32615
FDA Registration Numbers
- 1423662
- 1450662
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Source Documents
Other 510(k) Records For Product Code MQV
| 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 Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute | 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 |