PILLAR SA PTC— 510(k) K161129

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K161129 for PILLAR SA PTC, Substantially Equivalent on 2016-09-08. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2016-04-21
Decision date: 2016-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.