510(k) K120279
- Device
- NANOFUSE DBM
- Applicant
- NANOTHERAPEUTICS
- 510(k) number
- K120279
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-06
- Date received
- 2012-01-30
- 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
- No
Applicant Contact#
- Contact
- GREGG RITTER
- Address
- 13859 Progress Blvd. Suite 300 Alachua FL US 32615 32615
FDA Registration Numbers#
- 3005652161
- 3013176080
- 1417592
- 3005304945
- 3043620406
- 1225991
- 3003300673
- 2029447
- 3010097171
- 9610921
- 1000307092
- 1000194445
- 2029275
- 3004111573
- 1644312
- 3009882464
- 3012447612
- 3008514120
- 3014560508
- 3010473074
- 3016592693
- 3004774118
- 1030489
- 3000215346
- 3016851379
- 3008522639
- 1416980
- 1833920
- 3021988499
- 3008110533
- 1038671
- 3006788678
- 3009144915
- 1319660
- 1450662
- 3008773560
- 2531195
- 1526439
- 3012495575
- 3014211822
- 2032098
- 2031966
- 3013491327
- 3019403037
- 3016438694
- 3002808022
- 2249915
- 3010275504
- 1825034
- 9610726
- 3015542130
- 3014982332
- 3003828812
- 3010197239
- 3010560653
- 9681465
- 3005819474
- 3011415547
- 3000270450
- 3010202439
- 3015207155
- 1000577893
- 2027754
- 9610612
- 3008812251
- 3031563325
- 3033809758
- 1424263
- 3004549189
- 3035366890
- 3004024955
- 2024024
- 1043534
- 3038284487
- 2530154
- 3005581234
- 3005031160
- 9614442
- 3006404071
- 3021226419
Source Documents#
Other 510(k) Records For Product Code MQV #
| 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 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 |
Legacy Summary#
summary
FDA Review#
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