Clearance Summary
NOVOS-NAIL Limb Lengthening System (LLS) received FDA 510(k) clearance under submission number K163653, sponsored by Smith & Nephew. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-10-13.
- Submission: K163653
- Applicant / Sponsor: Smith & Nephew
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2017-10-13
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.