LBN — Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene Class II
FDA product code LBN covers "Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene", a Class II medical device regulated under 21 CFR 874.3495. Submissions are reviewed by the Ear, Nose, Throat 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
- LBN
- Device Class
- Class II
- Regulation Number
- 874.3495
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K822367 | treace medical | TOTAL | September 7, 1982 |