STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
Device Facts
| Record ID | K912190 |
|---|---|
| Device Name | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST |
| Applicant | Stryker Corp. |
| Product Code | JDZ · Orthopedic |
| Decision Date | Aug 29, 1991 |
| 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).