CORIN UNIPOLAR MODULAR HEAD— 510(k) K063791

Name: FDA 510(k) clearance K063791
Creator: U.S. Food and Drug Administration
Published: 2007-04-03

Substantially Equivalent

Corin USA

FDA 510(k) clearance K063791 for CORIN UNIPOLAR MODULAR HEAD, Substantially Equivalent on 2007-04-03. Applicant: Corin USA. Device class: 2.

Clearance details

Applicant: Corin USA
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2006-12-22
Decision date: 2007-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.