Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060) → JDN — Implant, Fixation Device, Spinal

# JDN · Implant, Fixation Device, Spinal

_Orthopedic · 21 CFR 888.3060 · Class 2_

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

## Overview

- **Product Code:** JDN
- **Device Name:** Implant, Fixation Device, Spinal
- **Regulation:** [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

## Classification Rationale

Class II.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K954856](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K954856.md) | CANNULATED FEMORAL NAIL | Synthes (Usa) | Mar 8, 1996 | SESE |
| [K897141](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K897141.md) | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Stuart | Jun 21, 1990 | SN |
| [K894184](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K894184.md) | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | Biedermann Motech GmbH | Apr 25, 1990 | SN |
| [K873977](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K873977.md) | NEW C-D SYSTEM FOR SPINAL SURGERY | Sofamor Co. | Dec 7, 1987 | SN |
| [K872715](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K872715.md) | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Roseburg SA | Dec 7, 1987 | SN |
| [K760649](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K760649.md) | TOTAL SPINAL CORRECTION | Depuy, Inc. | Oct 5, 1976 | SESE |

## Top Applicants

- Biedermann Motech GmbH — 1 clearance
- Depuy, Inc. — 1 clearance
- Roseburg SA — 1 clearance
- Sofamor Co. — 1 clearance
- Stuart — 1 clearance

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

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