Porous Polyethylene Ossicular Replacement
A porous polyethylene ossicular replacement is a surgically implanted prosthesis used in otologic surgery to reconstruct damaged or absent middle ear ossicles (the small bones of hearing) in patients with conductive hearing loss. FDA Class 2 classification is assigned, requiring 510(k) premarket notification. The product code is LBM, regulated under 21 CFR 874.3450, in the Ear, Nose, Throat specialty. This device is flagged as an implant.
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Basic Information
- Product Code
- LBM
- Device Class
- FDA class 2
- Regulation Number
- 874.3450
- 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 2 510(k) clearances via K numbers.
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.