K242431
- 510(k) number
- K242431
- Device name
- Omnia Medical PsiF DNA System
- Applicant
- Omnia Medical, LLC WV · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-06-06
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242431.pdf
Official FDA record: K242431
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.