NOVATION SPLINED RDD FEMORAL STEMS— 510(k) K063279

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K063279 for NOVATION SPLINED RDD FEMORAL STEMS, Substantially Equivalent on 2006-11-29. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2006-10-31
Decision date: 2006-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

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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.