AZURE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k) clearance K130825 · decided 2013-05-07
Clearance details
- K-number
- K130825
- Device name
- AZURE ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- Orthofix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-26
- Decision date
- 2013-05-07
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lewisville, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nit recall (Z-1089-2014) | Orthofix, Inc | 2014-02-25 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CervicalStim® (P030034/S017) | Orthofix, Inc. | 2022-06-14 |
| PhysioStim®, SpinalStim® (P850007/S046) | Orthofix, Inc. | 2022-06-14 |
| SpinalStim (P850007/S044) | Orthofix, Inc. | 2020-03-27 |
| CervicalStim (P030034/S015) | Orthofix, Inc. | 2019-10-08 |
| PhysioStim and SpinalStim (P850007/S043) | Orthofix, Inc. | 2019-10-08 |
| SpinalStim (P850007/S042) | Orthofix, Inc. | 2019-07-03 |
| PhysioStim and SpinalStim (P850007/S041) | Orthofix, Inc. | 2019-06-18 |
| CervicalStim (P030034/S014) | Orthofix, Inc. | 2019-06-18 |