K113320

Substantially Equivalent

NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12

Applicant: Exactech, Inc.
Product code: MEH
Advisory panel: Orthopedic
Date received: 2011-11-10
Decision date: 2012-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

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.