Product code KIH
- Device name
- Dispenser, Cement
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4200
- 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 |
|---|---|---|---|
| K042591 | SMARTMIX PRE-FILLED MIXING SYSTEM | DePuy Orthopaedics, Inc. | 2004-10-22 |
| K943906 | P.F.C. CEMENT PRESSURIZING SYSTEM | Johnson & Johnson Professionals, Inc. | 1994-12-21 |
| K897134 | CMW CEMENT PRESSURISATION SYSTEM | Dentsply Intl. | 1990-03-02 |
| K851881 | ORTHOPEADIC CEMENT DELIVERY SYSTEM | Dentsply Intl. | 1985-06-13 |
| K840046 | PRESSURIZING/SCAVENGING ACRYLIC CEMENT | Precision Medical Devices, Inc. | 1984-02-09 |
| K833675 | BRIGHAM TIBIAL CEMENT PRESSURIZER | Howmedica Corp. | 1983-12-12 |
| K811317 | HOWMEDICA FEMORAL PRESSURING SEAL | Howmedica Corp. | 1981-05-29 |
| K801388 | OH-HARRIS | Johnson & Johnson Professionals, Inc. | 1980-07-28 |
| K790275 | GUN, EXETER CEMENT | Howmedica Corp. | 1979-02-21 |
| K781955 | GUN, CEMENT | Depuy, Inc. | 1978-12-04 |
| K780266 | BONE CEMENT APPLICATOR | Zimmer, Inc. | 1978-02-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08031497003689 | Mendec® Kypho Set Monolateral 10 mm | TECRES SPA | 2025-12-17 |
| 08031497003696 | Mendec® Kypho Set Monolateral 15 mm | TECRES SPA | 2025-12-17 |
| 08031497003702 | Mendec® Kypho Set Monolateral 20 mm | TECRES SPA | 2025-12-17 |
| 08031497003801 | Mendec® Kypho Set Bilateral 10 mm | TECRES SPA | 2025-12-17 |
| 08031497003818 | Mendec® Kypho Set Bilateral 15 mm | TECRES SPA | 2025-12-17 |
| 08031497003825 | Mendec® Kypho Set Bilateral 20 mm | TECRES SPA | 2025-12-17 |
| 08053617184450 | Pressurizer | ADLER ORTHO SPA | 2025-10-07 |
| 08053617184467 | Pressurizer | ADLER ORTHO SPA | 2025-10-07 |
| 08053617184474 | Pressurizer | ADLER ORTHO SPA | 2025-10-07 |
| 08053617184481 | Pressurizer | ADLER ORTHO SPA | 2025-10-07 |
| 07640177820396 | Neo Medical Pedicle Screw System | Neo Medical SA | 2023-01-26 |
| 15060238200094 | SmartMix™ Narrow Straight Nozzle | SUMMIT MEDICAL LIMITED | 2022-11-23 |
| 15060238200087 | Prism™ Syringe Set | SUMMIT MEDICAL LIMITED | 2022-11-23 |
| 15060238200063 | PRISM™ II Vacuum Mixing Cartridge | SUMMIT MEDICAL LIMITED | 2022-11-23 |
| 10705034722641 | NA | Synthes GmbH | 2019-08-30 |
| 10705034722665 | NA | Synthes GmbH | 2019-08-29 |
| 10705034722672 | NA | Synthes GmbH | 2019-08-29 |
| 10603295174479 | NA | DEPUY ORTHOPAEDICS, INC. | 2018-09-24 |
| 10603295174516 | NA | DEPUY (IRELAND) | 2018-09-24 |
| 10603295202493 | SMARTMIX CEMVAC | DEPUY (IRELAND) | 2018-09-24 |
| 10603295168393 | SMARTSEAL | DEPUY (IRELAND) | 2018-09-24 |
| 10705034199528 | EXPEDIUM | Medos International Sàrl | 2017-05-02 |
| 10705034199566 | VIPER | Medos International Sàrl | 2017-05-02 |
| 10705034721705 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10705034721712 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10705034721729 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10705034721736 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10705034721743 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10603295174288 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168355 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |