NUGAIT(TM) SUBTALAR IMPLANT SYSTEM— 510(k) K111799

Substantially Equivalent

Ascension Orthopedic

FDA 510(k) clearance K111799 for NUGAIT(TM) SUBTALAR IMPLANT SYSTEM, Substantially Equivalent on 2011-08-19. Applicant: Ascension Orthopedic.

Clearance details

Applicant: Ascension Orthopedic
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2011-06-27
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.