K071064

Substantially Equivalent

ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA

Applicant: Ascension Orthopedics, Inc.
Product code: HSD
Advisory panel: Orthopedic
Date received: 2007-04-16
Decision date: 2007-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.