Harvester SI: Sacroiliac Fixation System— 510(k) K203780

Substantially Equivalent

Spinus International, Inc.

FDA 510(k) clearance K203780 for Harvester SI: Sacroiliac Fixation System, Substantially Equivalent on 2021-03-23. Applicant: Spinus International, Inc..

Clearance details

Applicant: Spinus International, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2020-12-28
Decision date: 2021-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Georgetown, TX, 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.