Clearance Summary
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM received FDA 510(k) clearance under submission number K093104, sponsored by Medyssey Co, 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 2010-06-25.
- Submission: K093104
- Applicant / Sponsor: Medyssey Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2010-06-25
Classification & Regulation
This clearance is catalogued under FDA product code MNI and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.