FDA Product Code
FDA Product Code HSX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3520
510(k) Clearances — 115 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K872735 | HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS. | Howmedica Corp. | 1987-08-04 | Traditional | PDF ↗ |
| K862632 | INSALL/BURSTEIN(TM)* II TIBIAL WEDGES | Zimmer, Inc. | 1987-03-25 | Traditional | PDF ↗ |
| K862837 | OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM | Osteonics Corp. | 1986-12-22 | Traditional | PDF ↗ |
| K862136 | MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE | Dow Corning Wright | 1986-07-14 | Traditional | PDF ↗ |
| K861715 | WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS | Dow Corning Wright | 1986-07-14 | Traditional | PDF ↗ |
| K854325 | TRICON UNICOMPARTMENTAL KNEE SYSTEM | Richards Medical Co., Inc. | 1985-12-09 | Traditional | PDF ↗ |
| K853020 | POROCOAT SYNATOMIC UNICONDYLAR KNEE | Depuy, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K853268 | FREEMAN UNI-COMPARTMENTAL KNEE | Protek, Inc. | 1985-09-04 | Traditional | PDF ↗ |
| K844706 | TRICON REVISION TOTAL KNEE SYSTEM | Richards Medical Co., Inc. | 1985-02-19 | Traditional | PDF ↗ |
| K844355 | SYNATOMIC STANDARD TIBIAL PLATEAU | Depuy, Inc. | 1985-02-07 | Traditional | PDF ↗ |
| K831513 | KENNEDY TIBIAL COMPONENT | Biomet, Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K803235 | GEO-TIBIAL RETAINER ROTATIONAL | Zimmer, Inc. | 1981-02-04 | Traditional | PDF ↗ |
| K800640 | MEDICAL COMPARTMENT KNEE PROSTHESIS | Dow Corning Wright | 1980-04-21 | Traditional | PDF ↗ |
| K792240 | POLYCENTRIC TOTAL KNEE METAL TIBIAL | Howmedica Corp. | 1979-12-05 | Traditional | PDF ↗ |
| K771511 | TOTAL KNEE PROSTHESIS-NONCONSTRAINED | 3M Company | 1977-11-30 | Traditional | PDF ↗ |
Product code HSX · Class II · Orthopedic. Data: openFDA.