K252351
- 510(k) number
- K252351
- Device name
- UniSpace® TPLIF Cage
- Applicant
- Cg Medtech Co., Ltd. KR
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-10-28
- Date received
- 2025-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K252351.pdf
Official FDA record: K252351
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.