LEFORTE SYSTEM BONE PLATE & SCREW— 510(k) K112457

Substantially Equivalent

Arkin Consulting Group

FDA 510(k) clearance K112457 for LEFORTE SYSTEM BONE PLATE & SCREW, Substantially Equivalent on 2012-05-18. Applicant: Arkin Consulting Group.

Clearance details

Applicant: Arkin Consulting Group
Product code: Code JEY
Advisory panel: Dental
Date received: 2011-08-26
Decision date: 2012-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Marietta, GA, 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.