Clearance Summary
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A received FDA 510(k) clearance under submission number K032212, sponsored by Kyphon, 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 2003-09-15.
- Submission: K032212
- Applicant / Sponsor: Kyphon, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2003-09-15
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.