21 CFR 888.4210 — Mixer, Cement, For Clinical Use
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4210
Identification
A cement mixer for clinical use is a device consisting of a container intended for use in mixing 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 |
|---|---|---|---|---|
| JDZ | Mixer, Cement, For Clinical Use | 1 | 13 |
