LBN

Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene

Product code: LBN
Device name: Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
Device class: Class 2
21 CFR: 21 CFR 874.3495
Medical specialty: Ear, Nose, Throat
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

Official FDA classification page: LBN

Classification and pathway per current FDA publications. Data from openFDA (CC0).