Integra Salto Total Ankle System— 510(k) K182878
Substantially EquivalentAscension Orthopedics
FDA 510(k) clearance K182878 for Integra Salto Total Ankle System, Substantially Equivalent on 2018-12-18. Applicant: Ascension Orthopedics.
Clearance details
- Applicant
- Ascension Orthopedics
- Product code
- Code HSN
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Adverse events under product code HSN
product code HSN- Death
- 3
- Injury
- 4,711
- Total
- 4,714
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.