BRIGHAM TIBIAL CEMENT PRESSURIZER
Device Facts
| Record ID | K833675 |
|---|---|
| Device Name | BRIGHAM TIBIAL CEMENT PRESSURIZER |
| Applicant | Howmedica Corp. |
| Product Code | KIH · Orthopedic |
| Decision Date | Dec 12, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.