Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4230](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4230) → KII — Tube, Cement Ventilation

# KII · Tube, Cement Ventilation

_Orthopedic · 21 CFR 888.4230 · Class 1_

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

## Overview

- **Product Code:** KII
- **Device Name:** Tube, Cement Ventilation
- **Regulation:** [21 CFR 888.4230](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4230)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement (§ 888.3027).

## 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 (0 of 0)

_No cleared devices on record._

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

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