Mixer, Cement, For Clinical Use
A Cement Mixer for Clinical Use is an orthopedic surgical instrument used to combine the components of polymethylmethacrylate (PMMA) bone cement under controlled conditions, often under vacuum, to reduce porosity and improve the mechanical properties of the resulting cement. It is classified as FDA Class 1 (lowest risk), subject only to general controls including proper labeling and manufacturing standards. The product code is JDZ, regulated under 21 CFR 888.4210, within the Orthopedic medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JDZ
- Device Class
- FDA class 1
- Regulation Number
- 888.4210
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934253 | EXACTECH ALL POLY ACETABULAR CUP | Apr 29, 1994 | Substantially Equivalent | Exactech, Inc. |
| K925025 | PRISM BONE CEMENT MIXING SYSTEM | Jan 05, 1994 | Substantially Equivalent | Depuy, Inc. |
| K912190 | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST | Aug 29, 1991 | Substantially Equivalent | Stryker Corp. |
| K892937 | REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS | Jun 22, 1989 | Substantially Equivalent | Dentsply Intl. |
| K861086 | ZIMMER VACUUM MIXING SYSTEM | Apr 14, 1986 | Substantially Equivalent | Zimmer, Inc. |
| K854077 | MIX EVAC II | Jan 31, 1986 | Substantially Equivalent for Some Indications | Stryker Corp. |
| K853310 | SIMPLEX ENHANCEMENT MIXER | Sep 11, 1985 | Substantially Equivalent | Howmedica Corp. |
| K851205 | CEMENTRIFUGE | Jul 16, 1985 | Substantially Equivalent | Biodynamic Technologies, Inc. |
| K843219 | ZIMMER BONE CEMENT CENTRIFUGATION SYS | Nov 29, 1984 | Substantially Equivalent | Zimmer, Inc. |
| K792186 | HOWMEDICA MIX-KIT II | Dec 05, 1979 | Substantially Equivalent | Howmedica Corp. |
| K780857 | MIXING BOWL & SPATULA, DISPOSABLE | Jun 13, 1978 | Substantially Equivalent | Howmedica Corp. |
| K760636 | ORTHOMIX | Oct 05, 1976 | Substantially Equivalent | Diemolding Corp. |
| K760617 | MIX EVAC BONE CEMENT | Oct 05, 1976 | Substantially Equivalent | Stryker Corp. |
FEI Numbers
This FDA classification entry is associated with 135 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 135 registration numbers. Click on an entry to view related FDA registrations.