Clearance Summary
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM received FDA 510(k) clearance under submission number K113219, sponsored by Ellipse Technologies, 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 2012-10-19.
- Submission: K113219
- Applicant / Sponsor: Ellipse Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2012-10-19
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.