Clearance Summary
SURGICAL DYNAMICS SPINAL RETRACTOR received FDA 510(k) clearance under submission number K002008, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2000-08-16.
- Submission: K002008
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2000-08-16
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.