510(k) K251522
- Device
- Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
- Applicant
- Bone Solutions, Inc.
- 510(k) number
- K251522
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-13
- Date received
- 2025-05-16
- 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
- Drew Diaz
- Address
- 5712 Colleyville Blvd. Suite 210 Colleyville TX US 76034 76034
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
- 2530154
- 3003300673
- 9710629
- 3015231789
- 3002808022
- 3031563325
- 3003455467
- 3019403037
- 3008650117
- 9681465
- 1058584
- 3010667733
- 2953359
- 3013680140
- 3010400367
- 1030489
- 3009217531
- 1000194445
- 3030412764
- 3002807310
- 3010413864
- 3008328709
- 3010473074
- 3038284487
- 2031966
- 3004681519
- 3009417901
- 3010560653
- 3011121816
- 3004024955
- 3014211822
- 3030991335
- 3000270450
- 2531321
- 1526534
- 3006524618
- 3015780293
- 3008812241
- 1319639
- 3014004349
- 3008812560
- 1038671
- 3004146122
- 3004549189
- 3015724777
- 1056553
- 1825034
- 3003477135
- 2647346
- 2245304
- 3000779542
- 3011324393
- 3014078231
- 3007225376
- 3003768919
- 3010160527
- 2249062
- 9615021
- 3006053983
- 3008102042
- 1220246
- 3007093114
- 1720929
- 3015946784
- 3015542130
- 3011795235
- 1000577893
- 3009973505
- 8030965
- 3008559295
- 3015207155
- 3003828812
- 3009905888
- 3012447612
- 3021015512
- 1221763
- 1220477
- 2531195
- 2030598
- 1047843
- 3006017180
- 3004450973
- 1000307092
- 3013491327
- 1225112
- 3012102437
- 9610726
- 3013497559
- 3002807408
- 3005652161
- 1032347
- 3002719998
- 2029275
- 1226544
- 1054811
- 3008114965
- 3033809758
- 2029447
- 3021988499
- 3016050940
- 3004111573
- 3014982332
- 3008868758
- 3000215346
- 3003775072
- 3008522639
- 1066368
- 3009595577
- 3035366890
- 3033509898
- 3027448274
- 1222747
- 3002673655
- 3011181154
- 3036756245
- 3002636527
- 9616944
- 3012448339
- 3013255153
- 3005381997
- 3007699035
- 3008812251
- 3005064037
- 3012161787
- 3012329552
- 9610921
- 2090010
- 3004788213
- 3010120148
- 3009144915
- 3014545238
- 3005304945
- 8043792
- 3011415547
- 2011171
- 2022435
- 3004774118
- 3011015097
- 3009882464
- 1424263
- 3016851379
- 3008812173
- 3014387294
- 3018094310
- 3010897183
- 3008583793
- 3021226419
- 3004847139
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 |
| 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 |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. | 2025-01-17 |