510(k) K250521
- Device
- NanoBone® SBX Putty ; NanoBone® QD
- Applicant
- Biocomposites, Ltd.
- 510(k) number
- K250521
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-07
- Date received
- 2025-02-21
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Ciara Airey
- Address
- Keel Science Park Keele GB ST55NL ST55NL
FDA Registration Numbers
- 1423662
- 1450662
- 3006788678
- 3043620406
- 3005180920
- 3013820501
- 1645368
- 1416980
- 3006404071
- 3013176080
- 2650143
- 3002807315
- 3010197239
- 3008147766
- 3011964577
- 2027062
- 1043534
- 1720734
- 3004464325
- 9617083
- 3011483489
- 3011662387
- 1824199
- 2032098
- 1644312
- 3010770940
- 2249915
- 3014560508
- 1833920
- 3025603301
- 3010258202
- 3012270469
- 3007738819
- 2031093
- 3008132398
- 3034676720
- 3004142400
- 1225991
- 3007193505
- 1219655
- 9610612
- 1526439
- 3010202439
- 2246552
- 1319660
- 2027754
- 1721676
- 3015219237
- 3005581234
- 3003771570
- 3005819474
- 9614442
- 3010162973
- 3016592693
- 3027339877
- 3005972619
- 2024024
- 3002807314
- 3008773560
- 9615788
- 3012495575
- 9611390
- 3009756327
- 3010376334
- 1417485
- 3006121828
- 2249852
- 3005031160
- 3010132111
- 3010331645
- 3011302692
- 1216032
- 3010275504
- 3016438694
- 3008514120
- 3013282271
- 3008110533
- 3009672666
- 3010097171
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |
| 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 |