THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE— 510(k) K994060

Substantially Equivalent

Bioplate, Inc.

FDA 510(k) clearance K994060 for THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE, Substantially Equivalent on 2001-01-24. Applicant: Bioplate, Inc..

Clearance details

Applicant: Bioplate, Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 1999-11-30
Decision date: 2001-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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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.