OAR · Injector, Vertebroplasty (Does Not Contain Cement)
Orthopedic · 21 CFR 888.4200 · Class 1
Overview
| Product Code | OAR |
|---|---|
| Device Name | Injector, Vertebroplasty (Does Not Contain Cement) |
| Regulation | 21 CFR 888.4200 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051820 | PARALLAX EZFLOW CEMENT DELIVERY SYSTEM | Arthrocare Corp. | Sep 6, 2005 | SESE |
Top Applicants
- Arthrocare Corp. — 1 clearance
