Definition: To Fill Bony Voids Or Gaps Of The Skeletal System (i.e. The Extremities, Posterolateral Spine And Pelvis).
| Device Type ID | 4749 |
| Device Name | Bone Void Filler, Syringe |
| Physical State | Pre-filled Syringe That Contains Putty Composed Of Bioactive Glass Particles, Polyethylene Glycol And Glycerol. Syringe Tip Permits Attachment Of Cannula. Syringe Also Includes Rotating Plunger To Aid In Controlled Dispersion Of Device. |
| Technical Method | Extruded From Syringe Into Bony Voids Or Gaps Of The Skeletal System (i.e., Extremities, Posterolateral Spine And Pelvis). |
| Target Area | Skeletal System (extremities, Posterolateral Spine And Pelvis). |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PBU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4749 |
| Device | Bone Void Filler, Syringe |
| Product Code | PBU |