Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
Information
Type
Rule
Regulated products
Medical Devices
Published
March 30, 2023
Last updated
March 30, 2023
Description
Document number 2023-06566. The Food and Drug Administration (FDA or Agency) is issuing a final rule to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately requiring the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)