K240250
- 510(k) number
- K240250
- Device name
- 3D Printed PEEK Interbody System
- Applicant
- Nvision Biomedical Technologies, Inc. TX · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-17
- Date received
- 2024-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K240250.pdf
Official FDA record: K240250
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.