Clearance Summary
HUCKSTEP INTRAMEDULLARY NAIL received FDA 510(k) clearance under submission number K811017, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1981-05-27.
- Submission: K811017
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1981-05-27
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.