Clearance Summary
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP received FDA 510(k) clearance under submission number K983942, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-12-04.
- Submission: K983942
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1998-12-04
Classification & Regulation
This clearance is catalogued under FDA product code JDS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.