Definition: Reduction Of Vertebral Body Fractures In Conjunction With PMMA Bone Cement Cleared For Vertebroplasty And Restoration Of Vertebral Body Height.
| Device Type ID | 4653 |
| Device Name | Cement, Bone, Pre-formed, Modular, Polymeric, Vertebroplasty |
| Physical State | Interlocking Pre-formed Polymeric (e.g., PEEK) Components Sized To The Desired Vertebral Body Dimensions |
| Technical Method | Implanted Modularly Within The Vertebral Body Until Desired Height Is Achieved, Then Encapsulated In PMMA. |
| Target Area | Thoracic Or Lumbar Vertebral Bodies |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| 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) |
| CFR Regulation Number | 888.3027 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4653 |
| Device | Cement, Bone, Pre-formed, Modular, Polymeric, Vertebroplasty |
| Product Code | OBL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| CFR Regulation Number | 888.3027 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |