SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
FDA 510(k) clearance K043270 · decided 2005-01-31
Clearance details
- K-number
- K043270
- Device name
- SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2004-11-26
- Decision date
- 2005-01-31
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sirus intramedullary nail for tibia, cannulated recall (Z-0247-2013) | Zimmer, Inc. | 2012-11-06 |
| Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zi recall (Z-1261-2009) | Zimmer Inc. | 2009-05-18 |