Clearance Summary
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K042673, sponsored by Alphatec/Nexmed. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-10-27.
- Submission: K042673
- Applicant / Sponsor: Alphatec/Nexmed
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2004-10-27
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.