Clearance Summary
SWANSON TITANIUM CARPAL LUNATE IMPLANT received FDA 510(k) clearance under submission number K864491, sponsored by Dow Corning Wright. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-04-15.
- Submission: K864491
- Applicant / Sponsor: Dow Corning Wright
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3750
- Decision date: 1987-04-15
Classification & Regulation
This clearance is catalogued under FDA product code KWN and 21 CFR 888.3750, within the Orthopedic review panel as a Class II device.