Product code MPW
- Device name
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Pma approved: P000054
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P000054S077 | INFUSE® Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2026-03-19 |
| P000054S076 | INFUSE Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2026-02-24 |
| P000054S074 | INFUSE® Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| P000054S073 | INFUSE™ Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| P000054S071 | INFUSE™ Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2023-10-06 |
| P000054S070 | INFUSE™ Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2023-08-21 |
| P000054S069 | INFUSE™ Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2023-08-21 |
| P000054S068 | Infuse™ Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2022-08-09 |
| P000054S067 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2022-06-09 |
| P000054S062 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2022-02-18 |
| P000054S066 | INFUSE™ Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2022-02-17 |
| P000054S060 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2021-11-08 |
| P000054S065 | INFUSE Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2021-04-05 |
| P000054S064 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2021-02-05 |
| P000054S061 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2020-12-30 |
| P000054S063 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2020-08-27 |
| P000054S059 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2020-07-10 |
| P000054S054 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2020-02-04 |
| P000054S055 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2019-12-13 |
| P000054S058 | INFUSE Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2019-12-04 |
| P000054S057 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2019-11-29 |
| P000054S056 | INFUSE Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2019-11-01 |
| P000054S053 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2019-07-24 |
| P000054S052 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2019-01-15 |
| P000054S051 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2018-11-09 |
| P000054S050 | INFUSE Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2018-08-29 |
| P000054S049 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2017-12-13 |
| P000054S048 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2017-06-21 |
| P000054S046 | Infuse Bone Graft | Medtronic Sofamor Danek USA, Inc. | 2017-03-03 |
| P000054S045 | INFUSE BONE GRAFT | Medtronic Sofamor Danek USA, Inc. | 2017-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00681490843829 | INFUSE® Bone Graft | MEDTRONIC SOFAMOR DANEK, INC. | 2014-09-23 |