← Product Code [JDN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN) · K897141

# SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (K897141)

_Stuart · JDN · Jun 21, 1990 · Orthopedic · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K897141

## Device Facts

- **Applicant:** Stuart
- **Product Code:** [JDN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN.md)
- **Decision Date:** Jun 21, 1990
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3060
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K897141](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDN/K897141)

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