Exactech® Novation® Element Press-fit Femoral Stem— 510(k) K153649

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K153649 for Exactech® Novation® Element Press-fit Femoral Stem, Substantially Equivalent on 2016-08-31. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2015-12-21
Decision date: 2016-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.