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

Cement Obturator

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

LZN is the FDA product code for Cement Obturator, a class II device type, regulated under 21 CFR 878.3300. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
LZN
Device name
Cement Obturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
37
Ingested recalls
8

Clearances, product code LZN

By decision year
37 clearances under product code LZN with a decision year between 1977 and 2022, 1994 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LZN by decision year
YearClearances
19771
19791
19811
19831
19852
19891
19902
19912
19921
19931
19945
19955
19963
19972
19991
20002
20012
20021
20031
20061
20221

Applicants with the most clearances

Product code LZN
Applicants holding the most 510(k) clearances under product code LZN
ApplicantClearances
Howmedica Corp.5
Allo Pro Corp.2
American Design Group, Inc.2
Isotis NV2
Johnson & Johnson Professionals, Inc.2
Sunmed, Inc.2
Biodynamic Technologies, Inc.1
Biomedical Devices, Inc.1
Biotron, Ltd.1
Cintor Orthopaedic Div.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order