Corin Optimized Positioning System (OPS) Plan— 510(k) K171847

Name: FDA 510(k) clearance K171847
Creator: U.S. Food and Drug Administration
Published: 2018-04-05

Substantially Equivalent

Corin U.S.A. Limited

FDA 510(k) clearance K171847 for Corin Optimized Positioning System (OPS) Plan, Substantially Equivalent on 2018-04-05. Applicant: Corin U.S.A. Limited. Device class: 2.

Clearance details

Applicant: Corin U.S.A. Limited
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2017-06-21
Decision date: 2018-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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K241570 — Unity Total Knee System2024-09-23
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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.