Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
FDA product code OBL · Class II (moderate risk) · 21 CFR 888.3027 · Orthopedic
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
1510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063606 | Modification to Staxx FX SystemOBL · Traditional | Spine Wave, Inc. | 04/13/2007SE |