Wrist Fracture System— 510(k) K251732
Substantially EquivalentMet One Technologies, LLC
FDA 510(k) clearance K251732 for Wrist Fracture System, Substantially Equivalent on 2026-02-12. Applicant: Met One Technologies, LLC. Device class: 2.
Summary
Met One Technologies filed a device named Wrist Fracture System under product code HRS, bone fixation plate. The name is generic, and the record doesn't describe the system further.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Met One Technologies filed from El Paso, Texas. The substantially equivalent decision came 251 calendar days after receipt (June 6, 2025 to February 12, 2026).
Clearance details
- Applicant
- Met One Technologies, LLC
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Paso, TX, US
Recent devices under product code HRS
view allMore clearances from Met One Technologies, LLC
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . 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.