ANOVA CONTAINMENT DEVICE
FDA 510(k) clearance K063461 · decided 2009-08-13
Clearance details
- K-number
- K063461
- Device name
- ANOVA CONTAINMENT DEVICE
- Applicant
- Anova Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-11-15
- Decision date
- 2009-08-13
- Days to decision
- 1002 days
- Clearance type
- Traditional
- Product code
- EZX
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPTIMESH (K014200) | Spineology, Inc. | 2003-11-26 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 (K032344) | Implex Corp. | 2003-10-02 |
| MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K032282) | Implex Corp. | 2003-08-21 |
| MACROPORE OS RECONSTRUCTION (K024169) | Macropore Biosurgery, Inc. | 2003-07-01 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K023882) | Implex Corp. | 2003-02-19 |
| NUVASIVE MESH (K020853) | Nuvasive, Inc. | 2002-06-13 |
| SYNTHES SYNMESH (K983766) | Synthes (Usa) | 1998-12-18 |
| TROCHANTER MESH (K945027) | Acu Med, Inc. | 1995-02-01 |
| MOTECH TITANIUM SURGICAL MESH (K900138) | Biedermann Motech GmbH | 1990-03-20 |
| TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM (K896369) | Techmedica, Inc. | 1989-11-24 |
| STUART TITANIUM SURGICAL MESH (K890601) | Stuart | 1989-03-16 |
Recalls involving this device
No recalls on record reference this clearance.