EZX · Class II · 21 CFR 878.3300

FDA Product Code EZX: Mesh, Surgical, Metal

Leading manufacturers include Implex Corp., Spineology, Inc. and Nuvasive, Inc..

12
Total
12
Cleared
205d
Avg days
1989
Since

FDA 510(k) Cleared Mesh, Surgical, Metal Devices (Product Code EZX)

12 devices
1–12 of 12
Cleared Aug 13, 2009
ANOVA CONTAINMENT DEVICE
K063461
Anova Corporation
General & Plastic Surgery · 1002d
Cleared Nov 26, 2003
OPTIMESH
K014200
Spineology, Inc.
General & Plastic Surgery · 705d
Cleared Oct 02, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
K032344
Implex Corp.
General & Plastic Surgery · 64d
Cleared Aug 21, 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282
Implex Corp.
General & Plastic Surgery · 28d
Cleared Jul 01, 2003
MACROPORE OS RECONSTRUCTION
K024169
Macropore Biosurgery, Inc.
General & Plastic Surgery · 195d
Cleared Feb 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882
Implex Corp.
General & Plastic Surgery · 90d
Cleared Jun 13, 2002
NUVASIVE MESH
K020853
Nuvasive, Inc.
General & Plastic Surgery · 90d
Cleared Dec 18, 1998
SYNTHES SYNMESH
K983766
Synthes (Usa)
General & Plastic Surgery · 53d
Cleared Feb 01, 1995
TROCHANTER MESH
K945027
Acu Med, Inc.
General & Plastic Surgery · 111d
Cleared Nov 24, 1989
TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM
K896369
Techmedica, Inc.
General & Plastic Surgery · 18d

About Product Code EZX - Regulatory Context