Clearance Summary
DYONICS FIXATION SCREWS received FDA 510(k) clearance under submission number K945182, sponsored by Smith & Nephew Dyonics, 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 1995-01-24.
- Submission: K945182
- Applicant / Sponsor: Smith & Nephew Dyonics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1995-01-24
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.