NOVATION CFS PRESS-FIT AND CEMENTED STEMS— 510(k) K090764

Name: FDA 510(k) clearance K090764
Creator: U.S. Food and Drug Administration
Published: 2009-04-21

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K090764 for NOVATION CFS PRESS-FIT AND CEMENTED STEMS, Substantially Equivalent on 2009-04-21. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2009-03-23
Decision date: 2009-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT2007-01-31
K062978 — U2 HIP STEM, TI PLASMA SPRAY2007-01-16

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.