K251472
- 510(k) number
- K251472
- Device name
- Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- Applicant
- Inion OY FI
- Product code
- HBW — Fastener, Plate, Cranioplasty
- Decision date
- 2025-07-11
- Date received
- 2025-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251472.pdf
Official FDA record: K251472
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.