ENDO HEAD— 510(k) K111145

Name: FDA 510(k) clearance K111145
Creator: U.S. Food and Drug Administration
Published: 2011-08-16

Substantially Equivalent

Medacta International

FDA 510(k) clearance K111145 for ENDO HEAD, Substantially Equivalent on 2011-08-16. Applicant: Medacta International. Device class: 2.

Clearance details

Applicant: Medacta International
Product code: Code LZY
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2011-04-22
Decision date: 2011-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZY

product code LZY

Injury: 431
Total: 431

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.