Clearance Summary
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System received FDA 510(k) clearance under submission number K251472, sponsored by Inion OY. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-07-11.
- Submission: K251472
- Applicant / Sponsor: Inion OY
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5360
- Decision date: 2025-07-11
Classification & Regulation
This clearance is catalogued under FDA product code HBW and 21 CFR 882.5360, within the Neurology review panel as a Class II device.