PRISM BONE CEMENT MIXING SYSTEM
Device Facts
| Record ID | K925025 |
|---|---|
| Device Name | PRISM BONE CEMENT MIXING SYSTEM |
| Applicant | Depuy, Inc. |
| Product Code | JDZ · Orthopedic |
| Decision Date | Jan 5, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4210 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (§ 888.3027).