Clearance Summary
4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) received FDA 510(k) clearance under submission number K121741, sponsored by 4-Web, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-10-18.
- Submission: K121741
- Applicant / Sponsor: 4-Web, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2012-10-18
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.