Clearance Summary
X-BOLT Hip Fracture Fixation System received FDA 510(k) clearance under submission number K181640, sponsored by X-Bolt Orthopaedics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-10-12.
- Submission: K181640
- Applicant / Sponsor: X-Bolt Orthopaedics
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2018-10-12
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.