Clearance Summary
Pro-X1 Trochanteric Nailing System received FDA 510(k) clearance under submission number K221621, sponsored by X-Bolt Orthopedics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-03-06.
- Submission: K221621
- Applicant / Sponsor: X-Bolt Orthopedics
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2023-03-06
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.