| K-number | K251790 |
| Device name | SeptAlign |
| Applicant | Spirair, Inc. |
| Product code | NHB |
| Device class | Class II |
| Decision date | Jan 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 874.3620 |
SeptAlign is a bioabsorbable implant made of polydioxanone that supports and straightens deviations in septal cartilage during septoplasty. The 190 mm implant with bi-directional anchors is placed using a minimally invasive delivery device and fully resorbs within 6 months, allowing the cartilage to remodel while supported in the corrected position.
No changes were made to the SeptAlign implant itself. Minor updates to the delivery device and packaging were implemented to improve ease of use and manufacturability, but these changes did not alter the device's technological characteristics or intended function.
ISO 11135-1:2014 for sterilization validation (SAL of 10⁻⁶); USP <85> Bacterial Endotoxin Test and AAMI ST72 for bacterial endotoxin testing; accelerated aging and distribution testing for packaging integrity and shelf-life performance.
View the full FDA submission: accessdata.fda.gov