BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
FDA 510(k) clearance K091976 · decided 2009-08-17
Clearance details
- K-number
- K091976
- Device name
- BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
- Applicant
- Biomet Trauma
- Decision
- Substantially Equivalent
- Date received
- 2009-07-01
- Decision date
- 2009-08-17
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Phoenix Nail System, intended for use with an intramedullary nail system for alignment, st recall (Z-1236-2018) | Zimmer Biomet, Inc. | 2018-03-27 |
| Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary recall (Z-1819-2016) | Biomet, Inc. | 2016-05-26 |