Clearance Summary
OXFORD EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K800184, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1980-02-11.
- Submission: K800184
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1980-02-11
Classification & Regulation
This clearance is catalogued under FDA product code JEC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.