Spinal system 510(k) guidance
This article was originally published in The Gray Sheet
Executive Summary
Degenerative disc disease (DDD) can be included as an indication for posterior, non-cervical pedicle screw systems, according to an FDA 1spinal device guidance issued May 3. Superseding guidance from 2000, the document applies to "most plate and rod-based" systems for fusion and to vertebral body replacement devices, and results from manufacturer input as well as a 1998 final rule (63 FR 40025) classifying and reclassifying pedicle screw systems. The guidance changes the product codes for pedicle screw uses, separating "MNI" for Class II screw use only, and "NKB" for Class III pre-amendments screw uses, which include DDD...