Clearance Summary
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance under submission number K152557, sponsored by G21, S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-02-23.
- Submission: K152557
- Applicant / Sponsor: G21, S.R.L.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2016-02-23
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.