Clearance Summary
4WEB OSTEOTOMY BONE WEDGE received FDA 510(k) clearance under submission number K130185, 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 2013-06-07.
- Submission: K130185
- Applicant / Sponsor: 4-Web, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2013-06-07
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.