Definition: Intended To Fill Bony Voids Or Gaps Of The Lower Extremities (pelvis Through Foot) That Are Not Intrinsic To The Stability Of The Bony Structure. These Defects May Be Surgically Created From Traumatic Injury To The Bone Including Bone Marrow Lesions.
| Device Type ID | 4757 |
| Device Name | Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions |
| Physical State | Various (including Granules, Pre-formed Blocks, Putties, Pastes, And Gels) |
| Technical Method | The Implanted Bone Void Filler Device Resorbs And Is Replaced With Bone During The Healing Process. |
| Target Area | Lower Extremities (pelvis Through Foot) |
| 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 | QCG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4757 |
| Device | Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions |
| Product Code | QCG |