Lever Action Plate System— 510(k) K200834

Name: FDA 510(k) clearance K200834
Creator: U.S. Food and Drug Administration
Published: 2020-06-25

Substantially Equivalent

Mcginley Orthpaedic Innovations, LLC

FDA 510(k) clearance K200834 for Lever Action Plate System, Substantially Equivalent on 2020-06-25. Applicant: Mcginley Orthpaedic Innovations, LLC. Device class: 2.

Clearance details

Applicant: Mcginley Orthpaedic Innovations, LLC
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2020-03-30
Decision date: 2020-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Casper, WY, US

Download summary PDF View on FDA.gov ↗

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K262963 — TMC Implant Fixation System2026-09-15
K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
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K262537 — Versalock Sterile Plating System2026-08-19

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.