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 |
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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 |