Definition: Stabilization Of The Posterior Thoracic And Lumbar Spine
Device Type ID | 4756 |
Device Name | Spinal Fixation System |
Physical State | The Spinal Rods And Connectors Are Made Of Titanium Alloy Per ASTM Standards. |
Technical Method | The Subject Spinal Rods And Connectors Attach To The Posterior Spine With Pedicle Screws And/ Or Hooks. |
Target Area | Posterior Thoracic And Lumbar Spine |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
Submission Type | Contact ODE |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | PWG |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4756 |
Device | Spinal Fixation System |
Product Code | PWG |