Clearance Summary
External Fixation Bone Distractor received FDA 510(k) clearance under submission number K251862, sponsored by Paragon 28, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-08-11.
- Submission: K251862
- Applicant / Sponsor: Paragon 28, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2025-08-11
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.