Reherniation Reduction Device
Device Code: 4758
Product Code(s):
QES Definition: The Device Is Intended To Reduce The Incidence Of Reherniation, And Reoperation Following Primary Limited Lumbar Discectomy Procedures (excision Of Herniated Intervertebral Disc).
Device Classification Information
| Device Type ID | 4758 |
| Device Name | Reherniation Reduction Device |
| Physical State | The Device Is Made Of A Metal Component With A Polymer Mesh Flap Intended To Cover The Annular Defect. |
| Technical Method | The Device Is Intended To Block The Annular Defect To Prevent Reherniation Of Nucleus Material. The Device Also Creates Lesion In The Vertebral Body That May Also Prevent The Herniation Of The Nucleus Material Out Of The Annulus. |
| Target Area | The Device Is Implanted Into The Vertebral Body And Rests In The Intervertebral Space Within The Annulus. |
| Review Panel | Orthopedic |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QES |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 4758 |
| Device | Reherniation Reduction Device |
| Product Code | QES |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 20:55:11