EXACTECH TAPERED WEDGE FEMORAL STEM— 510(k) K140674

Name: FDA 510(k) clearance K140674
Creator: U.S. Food and Drug Administration
Published: 2014-06-30

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K140674 for EXACTECH TAPERED WEDGE FEMORAL STEM, Substantially Equivalent on 2014-06-30. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2014-03-18
Decision date: 2014-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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K243448 — Equinoxe® Shoulder System2025-08-01
K243275 — Equinoxe® Scapula Fracture System2025-06-26
K243839 — Alteon® HA Femoral Stems2025-03-10

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.