OBL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
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| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO STAXX FX SYSTEM (K063606) | Spine Wave, Inc. | 2007-04-13 |
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