Clearance Summary
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) received FDA 510(k) clearance under submission number K812053, sponsored by Dow Corning Corp. Healthcare Industries Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1981-08-18.
- Submission: K812053
- Applicant / Sponsor: Dow Corning Corp. Healthcare Industries Materials
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3810
- Decision date: 1981-08-18
Classification & Regulation
This clearance is catalogued under FDA product code KXE and 21 CFR 888.3810, within the Orthopedic review panel as a Class II device.