Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4210](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4210) → JDZ — Mixer, Cement, For Clinical Use

# JDZ · Mixer, Cement, For Clinical Use

_Orthopedic · 21 CFR 888.4210 · Class 1_

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

## Overview

- **Product Code:** JDZ
- **Device Name:** Mixer, Cement, For Clinical Use
- **Regulation:** [21 CFR 888.4210](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4210)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A cement mixer for clinical use is a device consisting of a container intended for use in mixing 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 (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K934253](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K934253.md) | EXACTECH ALL POLY ACETABULAR CUP | Exactech, Inc. | Apr 29, 1994 | SESE |
| [K925025](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K925025.md) | PRISM BONE CEMENT MIXING SYSTEM | Depuy, Inc. | Jan 5, 1994 | SESE |
| [K912190](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K912190.md) | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST | Stryker Corp. | Aug 29, 1991 | SESE |
| [K892937](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K892937.md) | REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS | Dentsply Intl. | Jun 22, 1989 | SESE |
| [K861086](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K861086.md) | ZIMMER VACUUM MIXING SYSTEM | Zimmer, Inc. | Apr 14, 1986 | SESE |
| [K854077](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K854077.md) | MIX EVAC II | Stryker Corp. | Jan 31, 1986 | SN |
| [K853310](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K853310.md) | SIMPLEX ENHANCEMENT MIXER | Howmedica Corp. | Sep 11, 1985 | SESE |
| [K851205](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K851205.md) | CEMENTRIFUGE | Biodynamic Technologies, Inc. | Jul 16, 1985 | SESE |
| [K843219](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K843219.md) | ZIMMER BONE CEMENT CENTRIFUGATION SYS | Zimmer, Inc. | Nov 29, 1984 | SESE |
| [K792186](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K792186.md) | HOWMEDICA MIX-KIT II | Howmedica Corp. | Dec 5, 1979 | SESE |
| [K780857](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K780857.md) | MIXING BOWL & SPATULA, DISPOSABLE | Howmedica Corp. | Jun 13, 1978 | SESE |
| [K760636](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K760636.md) | ORTHOMIX | Diemolding Corp. | Oct 5, 1976 | SESE |
| [K760617](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDZ/K760617.md) | MIX EVAC BONE CEMENT | Stryker Corp. | Oct 5, 1976 | SESE |

## Top Applicants

- Howmedica Corp. — 3 clearances
- Stryker Corp. — 3 clearances
- Zimmer, Inc. — 2 clearances
- Biodynamic Technologies, Inc. — 1 clearance
- Dentsply Intl. — 1 clearance

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

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