Product code JDZ
- Device name
- Mixer, Cement, For Clinical Use
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4210
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934253 | EXACTECH ALL POLY ACETABULAR CUP | Exactech, Inc. | 1994-04-29 |
| K925025 | PRISM BONE CEMENT MIXING SYSTEM | Depuy, Inc. | 1994-01-05 |
| K912190 | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST | Stryker Corp. | 1991-08-29 |
| K892937 | REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS | Dentsply Intl. | 1989-06-22 |
| K861086 | ZIMMER VACUUM MIXING SYSTEM | Zimmer, Inc. | 1986-04-14 |
| K854077 | MIX EVAC II | Stryker Corp. | 1986-01-31 |
| K853310 | SIMPLEX ENHANCEMENT MIXER | Howmedica Corp. | 1985-09-11 |
| K851205 | CEMENTRIFUGE | Biodynamic Technologies, Inc. | 1985-07-16 |
| K843219 | ZIMMER BONE CEMENT CENTRIFUGATION SYS | Zimmer, Inc. | 1984-11-29 |
| K792186 | HOWMEDICA MIX-KIT II | Howmedica Corp. | 1979-12-05 |
| K780857 | MIXING BOWL & SPATULA, DISPOSABLE | Howmedica Corp. | 1978-06-13 |
| K760617 | MIX EVAC BONE CEMENT | Stryker Corp. | 1976-10-05 |
| K760636 | ORTHOMIX | Diemolding Corp. | 1976-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15060238201008 | Quick-Vac Vacuum Mixing Bowl | SUMMIT MEDICAL LIMITED | 2022-12-06 |
| 15060238201268 | OptiTwist® | SUMMIT MEDICAL LIMITED | 2022-12-02 |
| 15060238201015 | Quick-Vac Vacuum Mixing Bowl | SUMMIT MEDICAL LIMITED | 2022-11-24 |
| 08033860003449 | BIOPSYBELL | BIOPSYBELL SRL | 2022-09-16 |
| 10195327041342 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-04-10 |
| 15060238200513 | Mixing bowl, Spatula | SUMMIT MEDICAL LIMITED | 2021-12-01 |
| 15060238200285 | HiVac™ Bowl Bone Cement Mixing System | SUMMIT MEDICAL LIMITED | 2021-12-01 |
| 15060238200179 | Mixing bowl, Spatula | SUMMIT MEDICAL LIMITED | 2021-12-01 |
| 15060238200070 | SmartMix™ CTS Vacuum Mixing Bowl | SUMMIT MEDICAL LIMITED | 2021-12-01 |
| 10843717107375 | Midway Select | MIDWAY DENTAL SUPPLY, LLC | 2020-12-25 |
| 10843717107368 | Midway Select | MIDWAY DENTAL SUPPLY, LLC | 2020-12-25 |
| 10843717107351 | Midway Select | MIDWAY DENTAL SUPPLY, LLC | 2020-12-25 |
| 10843717107344 | Midway Select | MIDWAY DENTAL SUPPLY, LLC | 2020-12-25 |
| 15060238200742 | MiniMix LV | SUMMIT MEDICAL LIMITED | 2019-10-30 |
| 10304040095697 | Henry Schein | HENRY SCHEIN, INC. | 2019-08-28 |
| 07613154169665 | Revolution | STRYKER CORPORATION | 2018-09-24 |
| 07613154805464 | NA | STRYKER CORPORATION | 2018-09-24 |
| 07613154358335 | MixEvac | STRYKER CORPORATION | 2018-09-24 |
| 07613154170982 | Revolution | STRYKER CORPORATION | 2018-09-24 |
| 07613154169696 | Revolution | STRYKER CORPORATION | 2018-09-24 |
| 07613154169689 | Revolution, ACM | STRYKER CORPORATION | 2018-09-24 |
| 07613154169672 | Revolution | STRYKER CORPORATION | 2018-09-24 |
| 08033860028022 | ZAVATION | BIOPSYBELL SRL | 2018-02-26 |
| 07613327357851 | PCD, VertaPlex | STRYKER CORPORATION | 2017-04-21 |
| 07613252039259 | AutoPlex, VertaPlex | STRYKER CORPORATION | 2017-01-03 |
| 07613252018315 | PCD, VertaPlex | STRYKER CORPORATION | 2016-12-29 |
| 07613154687169 | AutoPlex, VertaPlex | STRYKER CORPORATION | 2016-12-29 |
| 07613154687152 | AutoPlex, VertaPlex | STRYKER CORPORATION | 2016-12-29 |
| 10603295168355 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295174288 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |