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 |
|---|---|---|---|
| 00840456223802 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223796 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223789 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223659 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223642 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223635 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223628 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456207130 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456207123 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456203163 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 06951233721733 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-05-15 |
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| 06951233721672 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-05-15 |
| 06951233721665 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-05-15 |
| 06951233721658 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-05-15 |
| 06951233721634 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-05-15 |
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| 06951233721603 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-05-13 |
| 06951233720897 | PALABOWL | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-04-11 |
| 04260102136038 | Heraeus | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-04-11 |
| 06951233720552 | CLEANEST | Guangzhou Clean Medical Products Manufacturing Corp. | 2024-03-22 |
| 06951233720644 | EASYMIX® bowl | Guangzhou Clean Medical Products Manufacturing Corp. | 2022-12-12 |
| 06951233720521 | Clean | Guangzhou Clean Medical Products Manufacturing Corp. | 2019-06-03 |
| 07613154169665 | Revolution | STRYKER CORPORATION | 2018-09-24 |