Clearance Summary
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* received FDA 510(k) clearance under submission number K973281, 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 1997-11-03.
- Submission: K973281
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1997-11-03
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.