KWN — Prosthesis, Wrist, Carpal Lunate Class II
FDA product code KWN covers "Prosthesis, Wrist, Carpal Lunate", a Class II medical device regulated under 21 CFR 888.3750. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWN
- Device Class
- Class II
- Regulation Number
- 888.3750
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K141920 | arthrosurface | Wrist Hemiarthroplasty System | December 23, 2014 |
| K080997 | ascension orthopedics | ASCENSION PYROCARBON LUNATE | June 17, 2008 |
| K050028 | biomet manufacturing | MAESTRO CARPAL HEMIARTHROPLASTY | March 25, 2005 |
| K864491 | dow corning wright | SWANSON TITANIUM CARPAL LUNATE IMPLANT | April 15, 1987 |
| K790793 | howmedica | AMC R METACARPAL COMPONENT | June 22, 1979 |