Clearance Summary
TRIGEN Low Profile Bone Screws received FDA 510(k) clearance under submission number K161264, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-11-23.
- Submission: K161264
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2016-11-23
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.