510(k) K081227
- Device
- PLEXUR M
- Applicant
- OSTEOTECH, INC.
- 510(k) number
- K081227
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-22
- Date received
- 2008-04-30
- 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
- CHRIS TALBOT
- Address
- 51 James Way Eatontown NJ US 07724 07724
FDA Registration Numbers#
- 3011415547
- 3008812251
- 3008812560
- 3036756245
- 3011662387
- 1416980
- 3034676720
- 3010400367
- 3021226419
- 3004142400
- 3011181154
- 3027339877
- 3002673655
- 9610612
- 3002719998
- 3011483489
- 3031563325
- 3004681519
- 3005381997
- 1720929
- 3015780293
- 3003775072
- 3016050940
- 1066368
- 9681465
- 3015724777
- 3007225376
- 1417592
- 1043534
- 3011121816
- 2249062
- 3014545238
- 3005031160
- 3004549189
- 3011795235
- 1032347
- 2530154
- 3005304945
- 1222747
- 3015542130
- 3019403037
- 3008773560
- 3012447612
- 3003477135
- 3016592693
- 2027062
- 2249852
- 3013497559
- 3016851379
- 2031093
- 3033809758
- 3014387294
- 2032098
- 3010197239
- 3013680140
- 3004464325
- 3015207155
- 3002807408
- 2030598
- 3003455467
- 3000215346
- 9617083
- 3002807314
- 3010473074
- 3011964577
- 1225112
- 9614442
- 3000270450
- 1417485
- 3011302692
- 3004788213
- 3007193505
- 3015542154
- 3008132398
- 3005180920
- 3005652161
- 3010258202
- 3009905888
- 2090010
- 3014004349
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 |
Legacy Summary#
summary
FDA Review#
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