MIOT PLATING SYSTEM— 510(k) K051945

Name: FDA 510(k) clearance K051945
Creator: U.S. Food and Drug Administration
Published: 2005-09-06

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K051945 for MIOT PLATING SYSTEM, Substantially Equivalent on 2005-09-06. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant: Orthofix Srl
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2005-07-18
Decision date: 2005-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, US

Download summary PDF View on FDA.gov ↗

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K261511 — Xpert Ankle2026-07-28

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K242270 — OrthoNext Platform System2024-12-19
K242861 — TrueLok Elevate2024-12-03

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.