UNITY Sacroiliac Joint Fixation System— 510(k) K173201

Substantially Equivalent

Huvexel Co. , Ltd.

FDA 510(k) clearance K173201 for UNITY Sacroiliac Joint Fixation System, Substantially Equivalent on 2018-04-26. Applicant: Huvexel Co. , Ltd..

Clearance details

Applicant: Huvexel Co. , Ltd.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2017-10-02
Decision date: 2018-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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.