Clearance Summary
PRECISION SCREW DRIVER SET received FDA 510(k) clearance under submission number K872389, sponsored by Med-Tool, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-07-15.
- Submission: K872389
- Applicant / Sponsor: Med-Tool, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1987-07-15
Classification & Regulation
This clearance is catalogued under FDA product code HXX and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.