Lucent 3D Spinal System— 510(k) K203254

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K203254 for Lucent 3D Spinal System, Substantially Equivalent on 2021-03-26. Applicant: Spinal Elements, Inc..

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2020-11-04
Decision date: 2021-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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.