# Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
> **Food and Drug Administration** · Final rule. · Published 2023-03-30 · Effective 2023-05-01 · 88 FR 18987
## Document
- **Document number:** 2023-06566
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 88 FR 18987
- **CFR reference:** 21 CFR 888
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion)
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