Clearance Summary
ZEE TRACTION SPLINT received FDA 510(k) clearance under submission number K813016, sponsored by Zee Medical Products Co., 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 1981-11-24.
- Submission: K813016
- Applicant / Sponsor: Zee Medical Products Co., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5850
- Decision date: 1981-11-24
Classification & Regulation
This clearance is catalogued under FDA product code HST and 21 CFR 888.5850, within the Orthopedic review panel as a Class I device.