K090764

Substantially Equivalent

NOVATION CFS PRESS-FIT AND CEMENTED STEMS

Applicant: Exactech, Inc.
Product code: LWJ
Advisory panel: Orthopedic
Date received: 2009-03-23
Decision date: 2009-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

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.