← Product Code [JEC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC) · K822780

# CERVICAL BRACE (K822780)

_Jerome Medical · JEC · Oct 6, 1982 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K822780

## Device Facts

- **Applicant:** Jerome Medical
- **Product Code:** [JEC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC.md)
- **Decision Date:** Oct 6, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K822780](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JEC/K822780)

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