Fiji Anchor— 510(k) K171228

Substantially Equivalent

Sportwelding GmbH

FDA 510(k) clearance K171228 for Fiji Anchor, Substantially Equivalent on 2018-01-19. Applicant: Sportwelding GmbH.

Clearance details

Applicant: Sportwelding GmbH
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2017-04-26
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schlieren, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.