Clearance Summary
Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance under submission number K172214, sponsored by G-21 S.R.L.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-08-23.
- Submission: K172214
- Applicant / Sponsor: G-21 S.R.L.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2017-08-23
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.