Clearance Summary
STS SCREW received FDA 510(k) clearance under submission number K032682, sponsored by Ortho-Pro, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-10-22.
- Submission: K032682
- Applicant / Sponsor: Ortho-Pro, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2003-10-22
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.