Clearance Summary
Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology received FDA 510(k) clearance under submission number K241605, sponsored by Nanovis, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-09-05.
- Submission: K241605
- Applicant / Sponsor: Nanovis, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2024-09-05
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.