Clearance Summary
NORM SPINAL SYSTEM received FDA 510(k) clearance under submission number K092011, sponsored by Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-10-28.
- Submission: K092011
- Applicant / Sponsor: Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2009-10-28
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.