Expandable Titanium PLIF/TLIF System— 510(k) K253377

Substantially Equivalent

Spectrum Spine, Inc.

FDA 510(k) clearance K253377 for Expandable Titanium PLIF/TLIF System, Substantially Equivalent on 2025-10-24. Applicant: Spectrum Spine, Inc..

Clearance details

Applicant: Spectrum Spine, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2025-09-30
Decision date: 2025-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Jasper, GA, 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.