Clearance Summary
LTD POLYAXIAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K041625, sponsored by Us Spinal Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-09-08.
- Submission: K041625
- Applicant / Sponsor: Us Spinal Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2004-09-08
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.