Clearance Summary
UNIVERSAL BUCKS TRACTION received FDA 510(k) clearance under submission number K823163, sponsored by Warm & Form, Orthopedic Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1982-11-10.
- Submission: K823163
- Applicant / Sponsor: Warm & Form, Orthopedic Materials
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5890
- Decision date: 1982-11-10
Classification & Regulation
This clearance is catalogued under FDA product code KQZ and 21 CFR 888.5890, within the Orthopedic review panel as a Class I device.