Clearance Summary
SMC 28MM CERAMIC FEMORAL HEADS received FDA 510(k) clearance under submission number K981302, sponsored by Signal Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-06-25.
- Submission: K981302
- Applicant / Sponsor: Signal Medical Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 1998-06-25
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.