KWK — Appliance, Nail/Blade/Plate Combination, Single Component Class II
FDA product code KWK covers "Appliance, Nail/Blade/Plate Combination, Single Component", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- KWK
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K931682 | onyx medical | CANNULATED MALLEOLAR SCREW | April 5, 1994 |