510(k) K173933
- Device
- Sorrento Bioglass Bone Graft Substitute
- Applicant
- Xenco Medical, LLC
- 510(k) number
- K173933
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-09-13
- Date received
- 2017-12-26
- 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
- gustavo Prado
- Address
- 9930 Mesa Rim Rd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3008812251
- 3008147766
- 3003771570
- 8030965
- 3015542130
- 2249852
- 1225991
- 3004464325
- 3009905888
- 1721676
- 3003455467
- 3005581234
- 3006404071
- 3010160527
- 3011964577
- 3009882464
- 1219655
- 1423662
- 1319639
- 3011302692
- 1644312
- 3010097171
- 3004549189
- 3011683674
- 1043534
- 3014004349
- 1032347
- 3010897183
- 2246552
- 3010202439
- 3011121816
- 1833920
- 1222747
- 3012161787
- 1225112
- 3002719998
- 2027754
- 3002807310
- 3010132111
- 3015946784
- 1424263
- 3004024955
- 9710629
- 3005180920
- 3011662387
- 3012329552
- 3005031160
- 3006017180
- 3005381997
- 3019403037
- 3008102042
- 3008559295
- 3002807314
- 3008522639
- 3030412764
- 3003775072
- 3000270450
- 2531321
- 3010120148
- 2011171
- 3008132398
- 2650143
- 3018094310
- 3005064037
- 3006053983
- 3010400367
- 3004774118
- 3005304945
- 3009144915
- 1000307092
- 3006121828
- 3002808022
- 1058584
- 3043620406
- 3005819474
- 2245304
- 1216032
- 3008650117
- 3013176080
- 3004681519
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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