Clearance Summary
Pantheon Pedicle Screw and Iliac Bolt Fixation System received FDA 510(k) clearance under submission number K241494, sponsored by Pantheon Spinal. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-07-26.
- Submission: K241494
- Applicant / Sponsor: Pantheon Spinal
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2024-07-26
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.