Clearance Summary
Intellitorq received FDA 510(k) clearance under submission number K180092, sponsored by Gauthier Biomedical, 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 2018-03-08.
- Submission: K180092
- Applicant / Sponsor: Gauthier Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2018-03-08
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.