510(k) K132377
- Device
- OSTEOSPAN MORPHEUS
- Applicant
- BIOGENNIX, LLC
- 510(k) number
- K132377
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-20
- Date received
- 2013-07-31
- 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
- ELAINE DUNCAN
- Address
- P.O. Box 560 Stillwater MN US 55082 55082
FDA Registration Numbers#
- 3002807408
- 3007738819
- 3004549189
- 3011483489
- 1000577893
- 3027448274
- 2249062
- 3008773560
- 2029275
- 2024024
- 3031563325
- 3005064037
- 3009882464
- 2029447
- 1056553
- 1066368
- 9610612
- 3008522639
- 3008650117
- 9615021
- 3008812241
- 1423662
- 3004450973
- 3011121816
- 3004146122
- 3002807314
- 3030991335
- 3016851379
- 3003300673
- 3006121828
- 3033509898
- 1000307092
- 3006788678
- 3010400367
- 3008110533
- 3015542130
- 3014545238
- 3021988499
- 3014004349
- 3010202439
- 1047843
- 3018094310
- 2011171
- 3007699035
- 3009973505
- 3010331645
- 1319639
- 3011324393
- 2530154
- 3008868758
- 1225991
- 2245304
- 3013255153
- 1720734
- 3010097171
- 3013491327
- 2031966
- 3009756327
- 3009144915
- 3012161787
- 3010560653
- 1032347
- 9617083
- 3014560508
- 9710629
- 3010120148
- 3014982332
- 8043792
- 3009595577
- 1526439
- 3004024955
- 2531195
- 1220477
- 3027339877
- 3015231789
- 3008812560
- 3008583793
- 3004847139
- 3015780293
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 |
| 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 |
| K250346 | BonVie+ | Elute, Inc. | 2025-02-26 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. | 2025-02-21 |
Legacy Summary#
summary
FDA Review#
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