Clearance Summary
SICAT IMPLANT V1.2 received FDA 510(k) clearance under submission number K103723, sponsored by Sicat GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-05-20.
- Submission: K103723
- Applicant / Sponsor: Sicat GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2011-05-20
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.