Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
A total ossicular replacement prosthesis made of porous polyethylene is a surgical implant designed to replace the entire ossicular chain in the middle ear, restoring sound conduction in patients with severe conductive hearing loss due to disease or trauma. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LBN, regulated under 21 CFR 874.3495, in the Ear, Nose, Throat specialty. This device is flagged as an implant.
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Basic Information
- Product Code
- LBN
- Device Class
- FDA class 2
- Regulation Number
- 874.3495
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K822367 | TOTAL | Sep 07, 1982 | Substantially Equivalent | Treace Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.