510(k) K062819— BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

Substantially Equivalent

Bioplate, Inc.

Clearance details

Applicant: Bioplate, Inc.
Product code: Code GXN
Advisory panel: Neurology
Date received: 2006-09-20
Decision date: 2006-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.