K251472 is an FDA 510(k) clearance for the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System. This device is classified as a Fastener, Plate, Cranioplasty (Class II - Special Controls, product code HBW).
Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on July 11, 2025, 59 days after receiving the submission on May 13, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5360.
| 510(k) Number | K251472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2025 |
| Decision Date | July 11, 2025 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBW - Fastener, Plate, Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5360 |