K042517

Substantially Equivalent

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS

Applicant: Linvatec Biomaterials, Ltd.
Product code: JEY
Advisory panel: Dental
Date received: 2004-09-15
Decision date: 2004-10-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.