CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS— 510(k) K111481

Name: FDA 510(k) clearance K111481
Creator: U.S. Food and Drug Administration
Published: 2012-02-06

Substantially Equivalent

Corin USA

FDA 510(k) clearance K111481 for CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS, Substantially Equivalent on 2012-02-06. Applicant: Corin USA. Device class: 2.

Clearance details

Applicant: Corin USA
Product code: Code OQI
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2011-05-27
Decision date: 2012-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K111481

K-number listed on FDA's recall record

Z-2606-2021 — Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.Class II·Terminated·Corin Ltd·20210728

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111481.

Data sourced from openFDA. This site is unofficial and independent of the FDA.