Clearance Summary
Joline Kyphoplasty System Allevo received FDA 510(k) clearance under submission number K192449, sponsored by Joline GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-05-27.
- Submission: K192449
- Applicant / Sponsor: Joline GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2020-05-27
Classification & Regulation
This clearance is catalogued under FDA product code NDN and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.