Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
fda-device · Food and Drug Administration · Rule · Published 2023-03-30 · Effective 2023-05-01 · 88 FR 18987
Document
Document number
2023-06566
Federal Register citation
88 FR 18987
CFR reference
21 CFR 888
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2023-03-30
Effective date
2023-05-01
HHS docket
Docket No. FDA-2021-N-0310
Abstract
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.