FDA Product Code
FDA Product Code KWN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3750
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014-12-23 | Traditional | PDF ↗ |
| K080997 | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | 2008-06-17 | Traditional | PDF ↗ |
| K050028 | MAESTRO CARPAL HEMIARTHROPLASTY | Biomet Manufacturing, Inc. | 2005-03-25 | Traditional | PDF ↗ |
| K864491 | SWANSON TITANIUM CARPAL LUNATE IMPLANT | Dow Corning Wright | 1987-04-15 | Traditional | PDF ↗ |
| K790793 | AMC R METACARPAL COMPONENT | Howmedica Corp. | 1979-06-22 | Traditional | PDF ↗ |
Product code KWN · Class II · Orthopedic. Data: openFDA.