KLS MINI OSTEOSYNTHESIS SYSTEM— 510(k) K943347

Name: FDA 510(k) clearance K943347
Creator: U.S. Food and Drug Administration
Published: 1994-10-04

Substantially Equivalent

Patton, Boggs & Blow

FDA 510(k) clearance K943347 for KLS MINI OSTEOSYNTHESIS SYSTEM, Substantially Equivalent on 1994-10-04. Applicant: Patton, Boggs & Blow. Device class: 2.

Clearance details

Applicant: Patton, Boggs & Blow
Product code: Code JEY
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 1994-07-12
Decision date: 1994-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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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.