# Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures
> **Food and Drug Administration** · Final amendment; final order. · Published 2023-03-30 · Effective 2023-05-01 · 88 FR 18990
## Document
- **Document number:** 2023-06565
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 88 FR 18990
- **CFR reference:** 21 CFR 888
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2023/03/30/2023-06565/effective-date-of-requirement-for-premarket-approval-applications-for-spinal-spheres-for-use-in)
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