ARTS2 SPINAL FIXATION SYSTEM— 510(k) K103573

Substantially Equivalent

Advanced Medical Technologies

FDA 510(k) clearance K103573 for ARTS2 SPINAL FIXATION SYSTEM, Substantially Equivalent on 2011-12-28. Applicant: Advanced Medical Technologies.

Clearance details

Applicant: Advanced Medical Technologies
Product code: 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

Download summary PDF View on FDA.gov ↗

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.