K250602
- 510(k) number
- K250602
- Device name
- X-PAC® N-GAGE Lumbar Plate System
- Applicant
- Expanding Innovations, Inc. CA · US
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2025-05-20
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250602.pdf
Official FDA record: K250602
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.