FDA Product Code
FDA Product Code KIH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.4200
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K042591 | SMARTMIX PRE-FILLED MIXING SYSTEM | DePuy Orthopaedics, Inc. | 2004-10-22 | Special | PDF ↗ |
| K943906 | P.F.C. CEMENT PRESSURIZING SYSTEM | Johnson & Johnson Professionals, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K897134 | CMW CEMENT PRESSURISATION SYSTEM | Dentsply Intl. | 1990-03-02 | Traditional | PDF ↗ |
| K851881 | ORTHOPEADIC CEMENT DELIVERY SYSTEM | Dentsply Intl. | 1985-06-13 | Traditional | PDF ↗ |
| K840046 | PRESSURIZING/SCAVENGING ACRYLIC CEMENT | Precision Medical Devices, Inc. | 1984-02-09 | Traditional | PDF ↗ |
| K833675 | BRIGHAM TIBIAL CEMENT PRESSURIZER | Howmedica Corp. | 1983-12-12 | Traditional | PDF ↗ |
| K811317 | HOWMEDICA FEMORAL PRESSURING SEAL | Howmedica Corp. | 1981-05-29 | Traditional | PDF ↗ |
| K801388 | OH-HARRIS | Johnson & Johnson Professionals, Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K790275 | GUN, EXETER CEMENT | Howmedica Corp. | 1979-02-21 | Traditional | PDF ↗ |
| K781955 | GUN, CEMENT | Depuy, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K780266 | BONE CEMENT APPLICATOR | Zimmer, Inc. | 1978-02-28 | Traditional | PDF ↗ |
Product code KIH · Class I · Orthopedic. Data: openFDA.