Clearance Summary
TORQUEDRIVER WRENCH received FDA 510(k) clearance under submission number K870053, sponsored by Jerome Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-03-11.
- Submission: K870053
- Applicant / Sponsor: Jerome Medical
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1987-03-11
Classification & Regulation
This clearance is catalogued under FDA product code HXC and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.