21 CFR § 888.4230 - Cement ventilation tube.

---
identifier: "/us/cfr/t21/s888.4230"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.4230 - Cement ventilation tube."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.4230"
section_name: "Cement ventilation tube."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 888.4230 Cement ventilation tube.

(a) *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).

(b) *Classification.* 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.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]