ORTHOPEADIC CEMENT DELIVERY SYSTEM
Device Facts
| Record ID | K851881 |
|---|---|
| Device Name | ORTHOPEADIC CEMENT DELIVERY SYSTEM |
| Applicant | Dentsply Intl. |
| Product Code | KIH · Orthopedic |
| Decision Date | Jun 13, 1985 |
| 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.
