BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS— 510(k) K042517

Substantially Equivalent

Linvatec Biomaterials, Ltd.

FDA 510(k) clearance K042517 for BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS, Substantially Equivalent on 2004-10-08. Applicant: Linvatec Biomaterials, Ltd..

Clearance details

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

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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.