MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices— 510(k) K231231

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K231231 for MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices, Substantially Equivalent on 2023-10-12. Applicant: Paragon 28, Inc..

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2023-04-28
Decision date: 2023-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.