Clearance Summary
APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET received FDA 510(k) clearance under submission number K961590, sponsored by Linvatec 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 1996-10-08.
- Submission: K961590
- Applicant / Sponsor: Linvatec Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1996-10-08
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.