Definition: Create Channels In The Existing Spinal Bone Structure For The Flow Of Polymethylmethacrylate Bone Cement (PMMA) Prior To A Vertebroplasty Procedure. Treatment Of Pathological Compression Fractures Of The Vertebral Body That May Result From Osteoporos
| Device Type ID | 4657 |
| Device Name | Spinal Channeling Instrument, Vertebroplasty |
| Physical State | Composed Of Cannula For Placement Within The Vertebral Body And Cutting Element That Is Deployed By The Surgeon Once The Cannula Is Placed. |
| Technical Method | Device Placed Within Cancellous Bone Of Vertebral Body And Then Cutting Element Advanced Forward Out Of Device By Surgeon To Create Channel For Cement Flow. |
| Target Area | Vertebral Body. |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.4540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OCJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4657 |
| Device | Spinal Channeling Instrument, Vertebroplasty |
| Product Code | OCJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 1 |
| Total Device Problems | 1 |