Clearance Summary
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL received FDA 510(k) clearance under submission number K132620, sponsored by Pan Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-04-16.
- Submission: K132620
- Applicant / Sponsor: Pan Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2014-04-16
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.