21 CFR 888.4200 — Dispenser, Cement
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4200
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIH | Dispenser, Cement | 1 | 11 | |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | 1 | 1 |
