SI Screw System— 510(k) K173752

Substantially Equivalent

Zavation Medical Products, LLC

FDA 510(k) clearance K173752 for SI Screw System, Substantially Equivalent on 2018-03-16. Applicant: Zavation Medical Products, LLC.

Clearance details

Applicant: Zavation Medical Products, LLC
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2017-12-08
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.