Clearance Summary
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO received FDA 510(k) clearance under submission number K021919, sponsored by Ortho Tec, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-07-03.
- Submission: K021919
- Applicant / Sponsor: Ortho Tec, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2002-07-03
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.