Baby Gorilla/Gorilla Plating System; Monster Screw System— 510(k) K241262

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K241262 for Baby Gorilla/Gorilla Plating System; Monster Screw System, Substantially Equivalent on 2024-06-05. Applicant: Paragon 28, Inc..

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2024-05-06
Decision date: 2024-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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.