Clearance Summary
CranioXpand received FDA 510(k) clearance under submission number K230211, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-11-21.
- Submission: K230211
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2023-11-21
Classification & Regulation
This clearance is catalogued under FDA product code PBJ and 21 CFR 882.5330, within the Neurology review panel as a Class II device.