Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4200](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4200) → OAR — Injector, Vertebroplasty (Does Not Contain Cement)

# OAR · Injector, Vertebroplasty (Does Not Contain Cement)

_Orthopedic · 21 CFR 888.4200 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/OAR

## Overview

- **Product Code:** OAR
- **Device Name:** Injector, Vertebroplasty (Does Not Contain Cement)
- **Regulation:** [21 CFR 888.4200](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4200)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K051820](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/OAR/K051820.md) | PARALLAX EZFLOW CEMENT DELIVERY SYSTEM | Arthrocare Corp. | Sep 6, 2005 | SESE |

## Top Applicants

- Arthrocare Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/OAR](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/OAR)

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