ISY — Joint, Knee, External Limb Component Class I
FDA product code ISY covers "Joint, Knee, External Limb Component", a Class I medical device regulated under 21 CFR 890.3420. 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
- ISY
- Device Class
- Class I
- Regulation Number
- 890.3420
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K101859 | rizzoli ortopedica | REL-K ARTIFICAL LIMB PROSTHESIS | October 13, 2010 |