Lucent Intervertebral Body Fusion Device— 510(k) K152011

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K152011 for Lucent Intervertebral Body Fusion Device, Substantially Equivalent on 2016-06-09. Applicant: Spinal Elements, Inc..

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2015-07-21
Decision date: 2016-06-09
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.