FDA Product Code QZY: Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating
A Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating Is A Rigid Metallic Implant System Compromised Of Single Or Multiple Components Intended To Provide Immobilization And Stabilization Of Spinal Segments As An Adjunct To Fusion In Skeletally Mature Patients. The Device Includes A 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating Intended To Reduce Microbial Contamination On The Surface Of The Device Prior To Implantation. The Device Does Not Contain Antimicrobial Agents That Act Within Or On The Body.
Leading manufacturers include Orthobond Coporation.
FDA 510(k) Cleared Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating Devices (Product Code QZY)
About Product Code QZY - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QZY since 2024, with 0 receiving FDA clearance (average review time: 767 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QZY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →