Clearance Summary
Archer PSI System received FDA 510(k) clearance under submission number K243509, sponsored by 3D-Side. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-05-12.
- Submission: K243509
- Applicant / Sponsor: 3D-Side
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2025-05-12
Classification & Regulation
This clearance is catalogued under FDA product code QHE and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.