510(k) K103440— EVEREST SPINAL SYSTEM

Substantially Equivalent

K2m, Inc.

Clearance details

Applicant: K2m, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2010-11-23
Decision date: 2011-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.