Effective Date of Requirement for Premarket Approval Applications for 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 18990
Document
Document number
2023-06565
Federal Register citation
88 FR 18990
CFR reference
21 CFR 888
Type
Rule
Action
Final amendment; final order.
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-0309
Abstract
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.