Definition: Maintain Position Of Bone Graft In Spinal Fusion Procedures. Intended For Use In Spinal Fusion Procedures As A Means To Maintain The Relative Position Of Weak Bony Tissue Such As Allografts Or Autografts, In Conjunction With Traditional Rigid Fixatio
| Device Type ID | 4661 |
| Device Name | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate |
| Physical State | Plates And Screws Made From Resorbable Materials Such Polylactic Acid |
| Technical Method | Attaches To Anterior Column Of Spine Using Screws |
| Target Area | Anterior Column Of Lumbar Or Cervical Spine |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OJB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4661 |
| Device | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate |
| Product Code | OJB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| CFR Regulation Number | 888.3060 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BEIJING NATON TECHNOLOGY GROUP CO. LTD. | ||
SE - WITH LIMITATIONS | 1 | |
INION | ||
SE - WITH LIMITATIONS | 1 | |
| Device Problems | |
|---|---|
Break | 1 |
Screw | 1 |
| Total Device Problems | 2 |