KITE Distal Fibula Kit— 510(k) K230623

Substantially Equivalent

Intrauma S.P.A

FDA 510(k) clearance K230623 for KITE Distal Fibula Kit, Substantially Equivalent on 2023-09-01. Applicant: Intrauma S.P.A.

Clearance details

Applicant: Intrauma S.P.A
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2023-03-06
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rivoli (To), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.