WRIGHT MEDICAL FETASAFE— 510(k) K892501

Substantially Equivalent

Wright Medical Corp.

FDA 510(k) clearance K892501 for WRIGHT MEDICAL FETASAFE, Substantially Equivalent on 1989-09-12. Applicant: Wright Medical Corp..

Clearance details

Applicant: Wright Medical Corp.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1989-04-05
Decision date: 1989-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.