Clearance Summary
Atlas Humeral Nail System received FDA 510(k) clearance under submission number K241484, sponsored by Orthopedic Designs North America, Inc. (Odi-Na). The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-11-05.
- Submission: K241484
- Applicant / Sponsor: Orthopedic Designs North America, Inc. (Odi-Na)
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2024-11-05
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.