PANTA NAIL (DIA. 10MM), PANTA NAIL XL
FDA 510(k) clearance K091788 · decided 2009-07-29
Clearance details
- K-number
- K091788
- Device name
- PANTA NAIL (DIA. 10MM), PANTA NAIL XL
- Applicant
- Newdeal Sas
- Decision
- Substantially Equivalent
- Date received
- 2009-06-17
- Decision date
- 2009-07-29
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis recall (Z-1736-2013) | Integra LifeSciences Corporation | 2013-07-16 |