# Orthopedic Devices; Classification for the Resorbable Calcium Salt Bone Void Filler Device
> **Food and Drug Administration** · Final rule. · Published 2003-06-02 · Effective 2003-07-02 · 68 FR 32635
## Document
- **Document number:** 03-13592
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 32635
- **CFR reference:** 21 CFR 888
- **Publication date:** 2003-06-02
- **Effective date:** 2003-07-02
- **HHS docket:** Docket No. 01N-0411
## Abstract

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/06/02/03-13592/orthopedic-devices-classification-for-the-resorbable-calcium-salt-bone-void-filler-device)
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