Clearance Summary
PARALLAX EZFLOW CEMENT DELIVERY SYSTEM received FDA 510(k) clearance under submission number K051820, sponsored by Arthrocare Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-09-06.
- Submission: K051820
- Applicant / Sponsor: Arthrocare Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4200
- Decision date: 2005-09-06
Classification & Regulation
This clearance is catalogued under FDA product code OAR and 21 CFR 888.4200, within the Orthopedic review panel as a Class I device.