Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3020](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3020) → NDE — Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible

# NDE · Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible

_Orthopedic · 21 CFR 888.3020 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDE

## Overview

- **Product Code:** NDE
- **Device Name:** Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
- **Regulation:** [21 CFR 888.3020](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3020)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDE](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDE)

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