COLS® FIXATION SYSTEM— 510(k) K120740

Substantially Equivalent

Fournitures Hospitalieres Industrie

FDA 510(k) clearance K120740 for COLS® FIXATION SYSTEM, Substantially Equivalent on 2013-03-05. Applicant: Fournitures Hospitalieres Industrie.

Clearance details

Applicant: Fournitures Hospitalieres Industrie
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2012-03-12
Decision date: 2013-03-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Quimper Finistere, FR

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.