PICCOLO COMPOSITE NAILING SYSTEM
FDA 510(k) clearance K111056 · decided 2011-05-03
Clearance details
- K-number
- K111056
- Device name
- PICCOLO COMPOSITE NAILING SYSTEM
- Applicant
- CarboFix Orthopedics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-18
- Decision date
- 2011-05-03
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzliya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of recall (Z-1991-2016) | CarboFix Orthopedics, Ltd. | 2016-06-14 |