Clearance Summary
HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K853033, sponsored by A.W. Showell (Surgicraft) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1985-09-24.
- Submission: K853033
- Applicant / Sponsor: A.W. Showell (Surgicraft) , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 1985-09-24
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.