510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LBMClass II

Porous Polyethylene Ossicular Replacement

21 CFR 874.3450 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LBM is the FDA product code for Porous Polyethylene Ossicular Replacement, a class II device type, regulated under 21 CFR 874.3450. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LBM
Device name
Porous Polyethylene Ossicular Replacement
Regulation
21 CFR 874.3450
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code LBM

By decision year
2 clearances under product code LBM with a decision year between 1982 and 1982, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LBM by decision year
YearClearances
19822

Applicants with the most clearances

Product code LBM
Applicants holding the most 510(k) clearances under product code LBM
ApplicantClearances
Treace Medical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code