Clearance Summary
TANGORS POLYAXIAL SYSTEM received FDA 510(k) clearance under submission number K052385, sponsored by Ulrich GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-12-27.
- Submission: K052385
- Applicant / Sponsor: Ulrich GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2005-12-27
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.