Clearance Summary
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION received FDA 510(k) clearance under submission number K123598, sponsored by Smith & Nephew, 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 2013-06-28.
- Submission: K123598
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3350
- Decision date: 2013-06-28
Classification & Regulation
This clearance is catalogued under FDA product code JDI and 21 CFR 888.3350, within the Orthopedic review panel as a Class II device.