21 CFR 888.4230 — Tube, Cement Ventilation
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4230
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KII | Tube, Cement Ventilation | 1 | 0 |
