JDZ · Mixer, Cement, For Clinical Use
Orthopedic · 21 CFR 888.4210 · Class 1
Overview
| Product Code | JDZ |
|---|---|
| Device Name | Mixer, Cement, For Clinical Use |
| Regulation | 21 CFR 888.4210 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (§ 888.3027).
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 (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934253 | EXACTECH ALL POLY ACETABULAR CUP | Exactech, Inc. | Apr 29, 1994 | SESE |
| K925025 | PRISM BONE CEMENT MIXING SYSTEM | Depuy, Inc. | Jan 5, 1994 | SESE |
| K912190 | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST | Stryker Corp. | Aug 29, 1991 | SESE |
| K892937 | REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS | Dentsply Intl. | Jun 22, 1989 | SESE |
| K861086 | ZIMMER VACUUM MIXING SYSTEM | Zimmer, Inc. | Apr 14, 1986 | SESE |
| K854077 | MIX EVAC II | Stryker Corp. | Jan 31, 1986 | SN |
| K853310 | SIMPLEX ENHANCEMENT MIXER | Howmedica Corp. | Sep 11, 1985 | SESE |
| K851205 | CEMENTRIFUGE | Biodynamic Technologies, Inc. | Jul 16, 1985 | SESE |
| K843219 | ZIMMER BONE CEMENT CENTRIFUGATION SYS | Zimmer, Inc. | Nov 29, 1984 | SESE |
| K792186 | HOWMEDICA MIX-KIT II | Howmedica Corp. | Dec 5, 1979 | SESE |
| K780857 | MIXING BOWL & SPATULA, DISPOSABLE | Howmedica Corp. | Jun 13, 1978 | SESE |
| K760636 | ORTHOMIX | Diemolding Corp. | Oct 5, 1976 | SESE |
| K760617 | MIX EVAC BONE CEMENT | Stryker Corp. | Oct 5, 1976 | SESE |
Top Applicants
- Stryker Corp. — 3 clearances
- Howmedica Corp. — 3 clearances
- Zimmer, Inc. — 2 clearances
- Exactech, Inc. — 1 clearance
- Diemolding Corp. — 1 clearance
