K251441
- 510(k) number
- K251441
- Device name
- Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- Applicant
- Inion OY FI
- Product code
- JEY — Plate, Bone
- Decision date
- 2025-11-07
- Date received
- 2025-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251441.pdf
Official FDA record: K251441
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.