Clearance Summary
SIMAL CERVICAL STABILIZATION SYSTEM received FDA 510(k) clearance under submission number K981008, sponsored by Top Surgical Products GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-05-27.
- Submission: K981008
- Applicant / Sponsor: Top Surgical Products GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 1998-05-27
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.