Clearance Summary
OPTIX H2 Patient Specific Instrument System received FDA 510(k) clearance under submission number K230462, sponsored by Vilex, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-07-17.
- Submission: K230462
- Applicant / Sponsor: Vilex, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3110
- Decision date: 2023-07-17
Classification & Regulation
This clearance is catalogued under FDA product code HSN and 21 CFR 888.3110, within the Orthopedic review panel as a Class II device.