Clearance Summary
FX-CABLELOK SYSTEM received FDA 510(k) clearance under submission number K922142, sponsored by Bio-Tech Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1992-11-20.
- Submission: K922142
- Applicant / Sponsor: Bio-Tech Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 1992-11-20
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.