K241605
- 510(k) number
- K241605
- Device name
- Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology
- Applicant
- Nanovis, LLC IN · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-05
- Date received
- 2024-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241605.pdf
Official FDA record: K241605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.