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

Mesh, Surgical, Metal

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

EZX is the FDA product code for Mesh, Surgical, Metal, a class II device type, regulated under 21 CFR 878.3300. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EZX
Device name
Mesh, Surgical, Metal
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
12
Ingested recalls
1

Clearances, product code EZX

By decision year
12 clearances under product code EZX with a decision year between 1989 and 2009, 2003 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code EZX by decision year
YearClearances
19892
19901
19951
19981
20021
20035
20091

Applicants with the most clearances

Product code EZX
Applicants holding the most 510(k) clearances under product code EZX
ApplicantClearances
Implex Corp.3
Acu Med, Inc.1
Anova Corporation1
Biedermann Motech GmbH1
Macropore Biosurgery, Inc.1
NuVasive Inc1
Spineology, Inc.1
Stuart1
Synthes (USA) Products LLC1
Techmedica, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order