OBL — Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty Class II
FDA product code OBL covers "Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty", a Class II medical device regulated under 21 CFR 888.3027. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OBL
- Device Class
- Class II
- Regulation Number
- 888.3027
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K063606 | spine wave | MODIFICATION TO STAXX FX SYSTEM | April 13, 2007 |