Corin BiPolar-i— 510(k) K183114

Name: FDA 510(k) clearance K183114
Creator: U.S. Food and Drug Administration
Published: 2019-06-05

Substantially Equivalent

Corin U.S.A. Limited

FDA 510(k) clearance K183114 for Corin BiPolar-i, Substantially Equivalent on 2019-06-05. Applicant: Corin U.S.A. Limited. Device class: 2.

Clearance details

Applicant: Corin U.S.A. Limited
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 2018-11-09
Decision date: 2019-06-05
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 KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.