Panta 2 Arthrodesis Nail System— 510(k) K181639
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K181639 for Panta 2 Arthrodesis Nail System, Substantially Equivalent on 2018-11-02. Applicant: Integra LifeSciences Corporation.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code HSB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.