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) → OJB — Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

# OJB · Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

_Orthopedic · 21 CFR 888.3060 · Class 2_

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

## Overview

- **Product Code:** OJB
- **Device Name:** Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K151360](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OJB/K151360.md) | Inion Spinal Graft Containment System | Inion OY | Oct 6, 2015 | SESU |
| [K071810](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OJB/K071810.md) | INION SPINAL GRAFT CONTAINMENT SYSTEM | Inion , Ltd. | Jul 11, 2008 | SESU |
| [K051821](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OJB/K051821.md) | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM | Inion , Ltd. | Nov 25, 2005 | SESE |

## Top Applicants

- Inion , Ltd. — 2 clearances
- Inion OY — 1 clearance

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

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