Cadence Total Ankle System— 510(k) K201507
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K201507 for Cadence Total Ankle System, Substantially Equivalent on 2020-06-29. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code HSN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3110
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Recent devices under product code HSN
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- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
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.