K103573

Substantially Equivalent

ARTS2 SPINAL FIXATION SYSTEM

Applicant: Advanced Medical Technologies
Product code: MNH
Advisory panel: Orthopedic
Date received: 2010-12-06
Decision date: 2011-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, 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.