Clearance Summary
COSMIC SYSTEM received FDA 510(k) clearance under submission number K080841, 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 2008-07-23.
- Submission: K080841
- Applicant / Sponsor: Ulrich GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2008-07-23
Classification & Regulation
This clearance is catalogued under FDA product code MNI and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.