Clearance Summary
ANTERIOR COMPACT SYSTEM received FDA 510(k) clearance under submission number K041469, sponsored by X-Spine Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-07-30.
- Submission: K041469
- Applicant / Sponsor: X-Spine Systems
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2004-07-30
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.