PF2— 510(k) K012062

Substantially Equivalent

Fixano SA

FDA 510(k) clearance K012062 for PF2, Substantially Equivalent on 2001-09-27. Applicant: Fixano SA.

Clearance details

Applicant: Fixano SA
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2001-07-02
Decision date: 2001-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.