Clearance Summary
SafeOp 3: Neural Informatix Systeem received FDA 510(k) clearance under submission number K234092, sponsored by Alphatec Spine, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-04-19.
- Submission: K234092
- Applicant / Sponsor: Alphatec Spine, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2024-04-19
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.