KIH — Dispenser, Cement Class I
FDA product code KIH covers "Dispenser, Cement", a Class I medical device regulated under 21 CFR 888.4200. Submissions are reviewed by the Orthopedic panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KIH
- Device Class
- Class I
- Regulation Number
- 888.4200
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042591 | depuy orthopaedics | SMARTMIX PRE-FILLED MIXING SYSTEM | October 22, 2004 |
| K943906 | johnson and johnson professionals | P.F.C. CEMENT PRESSURIZING SYSTEM | December 21, 1994 |
| K897134 | dentsply intl | CMW CEMENT PRESSURISATION SYSTEM | March 2, 1990 |
| K851881 | dentsply intl | ORTHOPEADIC CEMENT DELIVERY SYSTEM | June 13, 1985 |
| K840046 | precision medical devices | PRESSURIZING/SCAVENGING ACRYLIC CEMENT | February 9, 1984 |
| K833675 | howmedica | BRIGHAM TIBIAL CEMENT PRESSURIZER | December 12, 1983 |
| K811317 | howmedica | HOWMEDICA FEMORAL PRESSURING SEAL | May 29, 1981 |
| K801388 | johnson and johnson professionals | OH-HARRIS | July 28, 1980 |
| K790275 | howmedica | GUN, EXETER CEMENT | February 21, 1979 |
| K781955 | depuy | GUN, CEMENT | December 4, 1978 |
| K780266 | zimmer | BONE CEMENT APPLICATOR | February 28, 1978 |