ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)— 510(k) K122541

Name: FDA 510(k) clearance K122541
Creator: U.S. Food and Drug Administration
Published: 2012-09-20

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K122541 for ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP), Substantially Equivalent on 2012-09-20. 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: 2012-08-21
Decision date: 2012-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: West Linn, OR, US

Download summary PDF View on FDA.gov ↗

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K080590 — AOS PROXIMAL HUMERAL PLATE2008-05-06

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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.