KIH · Dispenser, Cement
Orthopedic · 21 CFR 888.4200 · Class 1
Overview
| Product Code | KIH |
|---|---|
| Device Name | Dispenser, Cement |
| Regulation | 21 CFR 888.4200 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.
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.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042591 | SMARTMIX PRE-FILLED MIXING SYSTEM | DePuy Orthopaedics, Inc. | Oct 22, 2004 | SESE |
| K943906 | P.F.C. CEMENT PRESSURIZING SYSTEM | Johnson & Johnson Professionals, Inc. | Dec 21, 1994 | SESE |
| K897134 | CMW CEMENT PRESSURISATION SYSTEM | Dentsply Intl. | Mar 2, 1990 | SESE |
| K851881 | ORTHOPEADIC CEMENT DELIVERY SYSTEM | Dentsply Intl. | Jun 13, 1985 | SESE |
| K840046 | PRESSURIZING/SCAVENGING ACRYLIC CEMENT | Precision Medical Devices, Inc. | Feb 9, 1984 | SESE |
| K833675 | BRIGHAM TIBIAL CEMENT PRESSURIZER | Howmedica Corp. | Dec 12, 1983 | SESE |
| K811317 | HOWMEDICA FEMORAL PRESSURING SEAL | Howmedica Corp. | May 29, 1981 | SESE |
| K801388 | OH-HARRIS | Johnson & Johnson Professionals, Inc. | Jul 28, 1980 | SESE |
| K790275 | GUN, EXETER CEMENT | Howmedica Corp. | Feb 21, 1979 | SESE |
| K781955 | GUN, CEMENT | Depuy, Inc. | Dec 4, 1978 | SESE |
| K780266 | BONE CEMENT APPLICATOR | Zimmer, Inc. | Feb 28, 1978 | SESE |
Top Applicants
- Howmedica Corp. — 3 clearances
- Johnson & Johnson Professionals, Inc. — 2 clearances
- Dentsply Intl. — 2 clearances
- Zimmer, Inc. — 1 clearance
- Precision Medical Devices, Inc. — 1 clearance
