Definition: The Device Acts As A Bone Void Filler And Consists Of A Filling Material And A Synthetic Peptide. It Is Intended To Fill Traumatic Or Surgically-created Defects That Are Not Intrinsic To The Bony Structure Of The Extremities, Spine Or Pelvis. It Will
| Device Type ID | 4737 |
| Device Name | Filler, Bone Void, Synthetic Peptide |
| 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 3 Medical Device |
| Product Code | NOX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4737 |
| Device | Filler, Bone Void, Synthetic Peptide |
| Product Code | NOX |
| FDA Device Classification | Class 3 Medical Device |