Hard Splint & Thermo-Adaptive Splint— 510(k) K241729

Substantially Equivalent

Whip Mix Corporation

FDA 510(k) clearance K241729 for Hard Splint & Thermo-Adaptive Splint, Substantially Equivalent on 2025-03-18. Applicant: Whip Mix Corporation.

Clearance details

Applicant: Whip Mix Corporation
Product code: Code MQC
Advisory panel: Unknown
Date received: 2024-06-14
Decision date: 2025-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.