Mesh, Surgical, Metal
The Surgical Metal Mesh (product code EZX) is a metallic implantable material used to reinforce or repair tissue during surgical procedures, such as hernia repair or pelvic floor reconstruction. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 878.3300 in the General and Plastic Surgery specialty. This device is designated as an implant.
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Basic Information
- Product Code
- EZX
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K063461 | ANOVA CONTAINMENT DEVICE | Aug 13, 2009 | Substantially Equivalent | Anova Corporation |
| K014200 | OPTIMESH | Nov 26, 2003 | Unknown | Spineology, Inc. |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | Oct 02, 2003 | Substantially Equivalent | Implex Corp. |
| K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Aug 21, 2003 | Substantially Equivalent | Implex Corp. |
| K024169 | MACROPORE OS RECONSTRUCTION | Jul 01, 2003 | Substantially Equivalent | Macropore Biosurgery, Inc. |
| K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Feb 19, 2003 | Substantially Equivalent | Implex Corp. |
| K020853 | NUVASIVE MESH | Jun 13, 2002 | Substantially Equivalent | Nuvasive, Inc. |
| K983766 | SYNTHES SYNMESH | Dec 18, 1998 | Substantially Equivalent | Synthes (Usa) |
| K945027 | TROCHANTER MESH | Feb 01, 1995 | Substantially Equivalent for Some Indications | Acu Med, Inc. |
| K900138 | MOTECH TITANIUM SURGICAL MESH | Mar 20, 1990 | Substantially Equivalent | Biedermann Motech GmbH |
| K896369 | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM | Nov 24, 1989 | Substantially Equivalent | Techmedica, Inc. |
| K890601 | STUART TITANIUM SURGICAL MESH | Mar 16, 1989 | Substantially Equivalent | Stuart |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.