MONT BLANC PEDICLE SCREW SYSTEMS— 510(k) K112684

Substantially Equivalent

Qualgenix

FDA 510(k) clearance K112684 for MONT BLANC PEDICLE SCREW SYSTEMS, Substantially Equivalent on 2012-05-01. Applicant: Qualgenix.

Clearance details

Applicant: Qualgenix
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2011-09-15
Decision date: 2012-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.