510(k) K171563
- Device
- MagnetOs Putty
- Applicant
- Kuros Biosciences B.V.
- 510(k) number
- K171563
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-24
- Date received
- 2017-05-30
- 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
- Yvonne P. Bovell
- Address
- Professor Bronkhorstlaan 10, Bldg. 48 Bilthoven NL 3723 MB 3723 MB
FDA Registration Numbers#
- 3007093114
- 3002636527
- 1225991
- 9615788
- 3012270469
- 3016851379
- 1824199
- 3003771570
- 3016438694
- 3012447612
- 9681465
- 2650143
- 3005652161
- 3011415547
- 3033809758
- 3011795235
- 1450662
- 3007699035
- 3010400367
- 3008114965
- 3014560508
- 3005064037
- 3010376334
- 3005031160
- 3011121816
- 3008868758
- 1216032
- 2531195
- 1032347
- 3012495575
- 2022435
- 3019403037
- 3006524618
- 3002673655
- 3007225376
- 3008812560
- 2953359
- 3011483489
- 1833920
- 3005581234
- 9617083
- 9610921
- 3003768919
- 3004549189
- 1030489
- 3002808022
- 3012102437
- 1526439
- 3013176080
- 1644312
- 3011181154
- 1054811
- 3008102042
- 2030598
- 3004146122
- 2249062
- 3003455467
- 3010258202
- 8043792
- 3010275504
- 3013255153
- 3009217531
- 3004847139
- 3009756327
- 3009905888
- 3009973505
- 3011662387
- 3016592693
- 8030965
- 3010897183
- 3010132111
- 3021226419
- 3002807315
- 1056553
- 3003828812
- 1225112
- 1424263
- 1720929
- 3035366890
- 3015946784
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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