510(k) K063461
- Device
- ANOVA CONTAINMENT DEVICE
- Applicant
- ANOVA CORPORATION
- 510(k) number
- K063461
- Product code
- EZX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-08-13
- Date received
- 2006-11-15
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Metal
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAMPBELL TUSKEY
- Address
- 2001 Pennsylvania Ave. NW Washington DC US 20006 20006
FDA Registration Numbers#
- 1226425
- 3004464325
- 1824199
- 3006128100
- 2024024
- 1526439
- 1835831
- 3008812560
- 1423662
- 8031010
- 3009941480
- 3000270450
- 1030489
- 3009417901
- 3015440604
- 8010177
- 3015531529
- 2647346
- 3015831087
- 3015212339
- 3008114965
- 3018094310
- 2135156
- 3008868758
- 1526534
- 3014725904
Source Documents#
Other 510(k) Records For Product Code EZX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K014200 | OPTIMESH | Spineology, Inc. | 2003-11-26 |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | Implex Corp. | 2003-10-02 |
| K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Implex Corp. | 2003-08-21 |
| K024169 | MACROPORE OS RECONSTRUCTION | Macropore Biosurgery, Inc. | 2003-07-01 |
| K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Implex Corp. | 2003-02-19 |
| K020853 | NUVASIVE MESH | Nuvasive, Inc. | 2002-06-13 |
| K983766 | SYNTHES SYNMESH | Synthes (Usa) | 1998-12-18 |
| K945027 | TROCHANTER MESH | Acu Med, Inc. | 1995-02-01 |
| K900138 | MOTECH TITANIUM SURGICAL MESH | Biedermann Motech GmbH | 1990-03-20 |
| K896369 | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM | Techmedica, Inc. | 1989-11-24 |
| K890601 | STUART TITANIUM SURGICAL MESH | Stuart | 1989-03-16 |
Legacy Summary#
summary
FDA Review#
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