OAR — Injector, Vertebroplasty (Does Not Contain Cement) Class I
FDA product code OAR covers "Injector, Vertebroplasty (Does Not Contain Cement)", a Class I medical device regulated under 21 CFR 888.4200. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OAR
- Device Class
- Class I
- Regulation Number
- 888.4200
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K051820 | arthrocare | PARALLAX EZFLOW CEMENT DELIVERY SYSTEM | September 6, 2005 |