IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)— 510(k) K173080

Substantially Equivalent

Huvexel Co. , Ltd.

FDA 510(k) clearance K173080 for IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF), Substantially Equivalent on 2017-10-31. Applicant: Huvexel Co. , Ltd..

Clearance details

Applicant: Huvexel Co. , Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2017-09-29
Decision date: 2017-10-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.