Auxilock GFS Mini, GFS II Large, and GFS Ultimate— 510(k) K213018

Substantially Equivalent

Auxein Medical Private Limited

FDA 510(k) clearance K213018 for Auxilock GFS Mini, GFS II Large, and GFS Ultimate, Substantially Equivalent on 2022-11-18. Applicant: Auxein Medical Private Limited.

Clearance details

Applicant: Auxein Medical Private Limited
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2021-09-20
Decision date: 2022-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sonipat, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.