510(k) K243526
- Device
- MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
- Applicant
- Orthocon, Inc.
- 510(k) number
- K243526
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-05
- Date received
- 2024-11-14
- Regulation
- 888.3045
- Classification name
- Filler, Bone Void, Calcium Compound
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Aniq Darr
- Address
- 700 Fairfield Ave., Suite 1 Stamford CT US 10533 10533
FDA Registration Numbers#
- 3010097171
- 2031966
- 2530154
- 9617083
- 1424263
- 3015219237
- 3006121828
- 1222747
- 1043534
- 3010160527
- 3003828812
- 9615021
- 1000577893
- 3014078231
- 3010560653
- 3035366890
- 3012447612
- 3007738819
- 1825034
- 3011121816
- 3015207155
- 3008328709
- 3010897183
- 3011302692
- 3011415547
- 3004111573
- 3000215346
- 3005180920
- 1056553
- 3014545238
- 2011171
- 3003300673
- 3013491327
- 3012495575
- 1000307092
- 2029447
- 3005652161
- 1054811
- 1058584
- 3010473074
- 3014982332
- 9616944
- 3004847139
- 3011015097
- 3008102042
- 3043620406
- 3009144915
- 3007225376
- 3009756327
- 3014004349
- 1833920
- 3014387294
- 3021015512
- 1319660
- 3008812251
- 3011483489
- 3004450973
- 3033809758
- 3011181154
- 1220246
- 3003768919
- 3015542130
- 3008559295
- 3013176080
- 2032098
- 1030489
- 3008868758
- 3009217531
- 3015542154
- 3012102437
- 9611390
- 9681465
- 3027339877
- 3025603301
- 1319639
- 2246552
- 2024024
- 1416980
- 1032347
- 3011795235
Source Documents#
Other 510(k) Records For Product Code MQV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250556 | Porous Biologic Scaffold | Ventris Medical | 2025-03-21 |