X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System— 510(k) K251617

Substantially Equivalent

Expanding Innovations, Inc.

FDA 510(k) clearance K251617 for X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System, Substantially Equivalent on 2025-06-16. Applicant: Expanding Innovations, Inc..

Clearance details

Applicant: Expanding Innovations, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2025-05-27
Decision date: 2025-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, 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.