FDA Product Code PLR: Spinal Vertebral Body Replacement Device - Cervical
Vertebral Body Replacement In The Cervical Spine.
Leading manufacturers include K2m, Inc., MiRus, LLC and Atlas Spine, Inc..
FDA 510(k) Cleared Spinal Vertebral Body Replacement Device - Cervical Devices (Product Code PLR)
About Product Code PLR - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code PLR since 2015, with 18 receiving FDA clearance (average review time: 170 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under PLR have taken an average of 89 days to reach a decision - down from 175 days historically, suggesting improved FDA processing for this classification.
PLR devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →