# Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems
> **Food and Drug Administration** · Final rule. · Published 1998-07-27 · Effective 1998-08-26 · 63 FR 40025
## Document
- **Document number:** 98-19944
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 40025
- **CFR reference:** 21 CFR 888
- **Publication date:** 1998-07-27
- **Effective date:** 1998-08-26
- **HHS docket:** Docket No. 95N-0176
## Abstract

The Food and Drug Administration (FDA) is classifying certain previously unclassified preamendments pedicle screw spinal systems into class II (special controls) and reclassifying certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. FDA is taking this action because it believes that special controls would provide reasonable assurance of safety and effectiveness. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/07/27/98-19944/orthopedic-devices-classification-and-reclassification-of-pedicle-screw-spinal-systems)
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