STRYKER CUSTOM TI IMPLANT— 510(k) K052871

Name: FDA 510(k) clearance K052871
Creator: U.S. Food and Drug Administration
Published: 2005-12-16

Substantially Equivalent

Stryker Leibinger

FDA 510(k) clearance K052871 for STRYKER CUSTOM TI IMPLANT, Substantially Equivalent on 2005-12-16. Applicant: Stryker Leibinger. Device class: 2.

Clearance details

Applicant: Stryker Leibinger
Product code: Code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2005-10-11
Decision date: 2005-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.