510(k) K112907— CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G

Substantially Equivalent

Medos International SARL

Clearance details

Applicant: Medos International SARL
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2011-10-03
Decision date: 2011-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.