510(k) K121016— RANGE SPINAL SYSTEM (MESA AND DENALI)

Substantially Equivalent

K2m, Inc.

Clearance details

Applicant: K2m, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2012-04-04
Decision date: 2012-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.