Piccolo Composite® Nailing System
FDA 510(k) clearance K153536 · decided 2016-01-06
Clearance details
- K-number
- K153536
- Device name
- Piccolo Composite® Nailing System
- Applicant
- CarboFix Orthopedics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-10
- Decision date
- 2016-01-06
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzeliya, 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 |