LBM · Class II · 21 CFR 874.3450

FDA Product Code LBM: Porous Polyethylene Ossicular Replacement

Leading manufacturers include Treace Medical, Inc..

2
Total
2
Cleared
17d
Avg days
1982
Since

FDA 510(k) Cleared Porous Polyethylene Ossicular Replacement Devices (Product Code LBM)

2 devices
1–2 of 2
Cleared Dec 03, 1982
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823441
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
FISCH MODIFIED TOTAL OSSICULAR PROSTHES
K823442
Treace Medical, Inc.
Ear, Nose, Throat · 17d

About Product Code LBM - Regulatory Context