510(k) K021684— THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

Substantially Equivalent

Bioplate, Inc.

Clearance details

Applicant: Bioplate, Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 2002-05-22
Decision date: 2002-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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.