BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP— 510(k) K112019

Name: FDA 510(k) clearance K112019
Creator: U.S. Food and Drug Administration
Published: 2011-10-12

Substantially Equivalent

Corentec Co., Ltd.

FDA 510(k) clearance K112019 for BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP, Substantially Equivalent on 2011-10-12. Applicant: Corentec Co., Ltd.. Device class: 2.

Clearance details

Applicant: Corentec Co., Ltd.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 2011-07-14
Decision date: 2011-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seocho Gu, Seoul, KR

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.