FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
FDA 510(k) clearance K102413 · decided 2011-11-14
Clearance details
- K-number
- K102413
- Device name
- FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
- Applicant
- Vilex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-24
- Decision date
- 2011-11-14
- Days to decision
- 447 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mcminnville, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo recall (Z-1721-2015) | Vilex In Tennessee Inc | 2015-06-08 |
| Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo recall (Z-1722-2015) | Vilex In Tennessee Inc | 2015-06-08 |
| Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo recall (Z-1723-2015) | Vilex In Tennessee Inc | 2015-06-08 |