K250335
- 510(k) number
- K250335
- Device name
- IVA & AEON Cervical and Lumbar Cage System
- Applicant
- K&J Consulting PA · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2025-08-29
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250335.pdf
Official FDA record: K250335
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.