KII · Tube, Cement Ventilation
Orthopedic · 21 CFR 888.4230 · Class 1
Overview
| Product Code | KII |
|---|---|
| Device Name | Tube, Cement Ventilation |
| Regulation | 21 CFR 888.4230 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement (§ 888.3027).
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 (0)
No cleared devices on record.
