Tyber Medical Distal Radius Plating System— 510(k) K251361

Name: FDA 510(k) clearance K251361
Creator: U.S. Food and Drug Administration
Published: 2025-07-30

Substantially Equivalent

Tyber Medical, LLC

FDA 510(k) clearance K251361 for Tyber Medical Distal Radius Plating System, Substantially Equivalent on 2025-07-30. Applicant: Tyber Medical, LLC. Device class: 2.

Clearance details

Applicant: Tyber Medical, LLC
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-05-01
Decision date: 2025-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

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K261060 — Navigated LLIF Impactable Tracker2026-05-29
K253042 — Tyber Medical Trauma Screw2026-04-03
K252901 — Tyber Medical Trauma Screw2025-12-31

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.