Clearance Summary
BIORCI SCREW received FDA 510(k) clearance under submission number K992396, sponsored by Smith & Nephew Endoscopy, 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 2000-01-12.
- Submission: K992396
- Applicant / Sponsor: Smith & Nephew Endoscopy, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2000-01-12
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.