Product code LBM— Ear, Nose, Throat

AUSTIN MODIFIED TOTAL OSSICULAR REPLACE

Classification name: Porous Polyethylene Ossicular Replacement
Device class: Class 2
Regulation: 21 CFR 874.3450
Advisory panel: Ear, Nose, Throat
Total cleared: 2
First cleared: 1982-12-03
Most recent: 1982-12-03

Market context for product code LBM

FDA has cleared 2 devices under product code LBM, all in 1982, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code LBM

Treace Medical, Inc.2 clearances

Recent clearances under product code LBM

K823441 — AUSTIN MODIFIED TOTAL OSSICULAR REPLACETreace Medical, Inc.·1982-12-03
K823442 — FISCH MODIFIED TOTAL OSSICULAR PROSTHESTreace Medical, Inc.·1982-12-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.