ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP— 510(k) K062920

Name: FDA 510(k) clearance K062920
Creator: U.S. Food and Drug Administration
Published: 2006-11-13

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K062920 for ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP, Substantially Equivalent on 2006-11-13. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant: Orthofix Srl
Product code: Code KTW
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2006-09-28
Decision date: 2006-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oregon City, OR, US

Download summary PDF View on FDA.gov ↗

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K160409 — AOS Anterolateral Proximal Humeral Plate2016-03-15
K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)2012-09-20

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Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.