STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM— 510(k) K022033

Substantially Equivalent

Bioplate, Inc.

FDA 510(k) clearance K022033 for STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM, Substantially Equivalent on 2002-07-19. Applicant: Bioplate, Inc..

Clearance details

Applicant: Bioplate, Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 2002-06-21
Decision date: 2002-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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.