510(k) K111944
- Device
- NB3D BONE VOID FILLER
- Applicant
- PIONEER SURGICAL TECHNOLOGY, INC.
- 510(k) number
- K111944
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-11-22
- Date received
- 2011-07-08
- 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
- FLOYD G LARSON
- Address
- 11234 El Camino Real Suite 200 San Diego CA US 92130 92130
FDA Registration Numbers#
- 3010197239
- 3007738819
- 2531195
- 3002807408
- 3003771570
- 3004146122
- 3009144915
- 9610921
- 3004549189
- 3000215346
- 3003300673
- 3010132111
- 3018085307
- 3010560653
- 3008583793
- 2090010
- 3008514120
- 3008328709
- 3010413864
- 2246552
- 2245304
- 2011171
- 3007193505
- 3006053983
- 1043534
- 3010162973
- 3012329552
- 3013680140
- 3030412764
- 3025603301
- 1054811
- 3013497559
- 9614442
- 3011181154
- 2650143
- 3015946784
- 3007093114
- 3011121816
- 1000577893
- 3034676720
- 9681465
- 2024024
- 1000194445
- 3015219237
- 3002807310
- 2031966
- 3010897183
- 3003768919
- 1225991
- 3006788678
- 3005652161
- 9617083
- 3015207155
- 3006524618
- 3011302692
- 3009217531
- 1721676
- 1417592
- 3003775072
- 3008650117
- 3033809758
- 3011964577
- 3003455467
- 1416980
- 3008132398
- 3010400367
- 1720734
- 3004111573
- 1222747
- 3005180920
- 2953359
- 3015542154
- 3021226419
- 3019403037
- 3009595577
- 2030598
- 3004142400
- 3004450973
- 1038671
- 3002807314
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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