Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures
Information
Type
Rule
Regulated products
Published
March 30, 2023
Last updated
March 30, 2023
Description
Document number 2023-06565. The Food and Drug Administration (FDA or Agency) is issuing a final order to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, an unclassified, preamendments device following the classification of the device into class III.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)