EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
FDA 510(k) clearance K090415 · decided 2009-06-01
Clearance details
- K-number
- K090415
- Device name
- EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
- Applicant
- Eminent Spine
- Decision
- Substantially Equivalent
- Date received
- 2009-02-18
- Decision date
- 2009-06-01
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Leander, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of s recall (Z-1418-2013) | Spinal Solutions, LLC | 2013-05-27 |