Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT020207

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel