ISW — Assembly, Knee/Shank/Ankle/Foot, External Class II
FDA product code ISW covers "Assembly, Knee/Shank/Ankle/Foot, External", a Class II medical device regulated under 21 CFR 890.3500. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ISW
- Device Class
- Class II
- Regulation Number
- 890.3500
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K991590 | otto bock orthopedic industry | C-LEG (3C100) | July 8, 1999 |