510(k) K092011— NORM SPINAL SYSTEM

Substantially Equivalent

Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar

Clearance details

Applicant: Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2009-07-06
Decision date: 2009-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankara, TR

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.