Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4580](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4580) → LZV — System, Cement Removal Extraction

# LZV · System, Cement Removal Extraction

_Orthopedic · 21 CFR 888.4580 · Class 2_

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

## Overview

- **Product Code:** LZV
- **Device Name:** System, Cement Removal Extraction
- **Regulation:** [21 CFR 888.4580](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4580)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

## Classification Rationale

Class II (special 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.

## Special Controls

*Classification.* Class II (special 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K021502](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LZV/K021502.md) | OSCAR, MODEL OE3000 | Orthosonics, Ltd. | Jun 6, 2002 | SESE |
| [K961101](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LZV/K961101.md) | STRYKER CEMENT REMOVAL SYSTEM | Stryker Corp. | Jul 15, 1996 | SESE |
| [K930629](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LZV/K930629.md) | ACRYL-X II SYSTEM | Sonokinetics, Inc. | Jan 21, 1994 | SESE |
| [K904156](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LZV/K904156.md) | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS | Origin Medsystems, Inc. | Nov 27, 1990 | SESE |
| [K904180](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LZV/K904180.md) | PROSTHETIC CEMENT REMOVER | Origin Medsystems, Inc. | Nov 20, 1990 | SESE |
| [K891472](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LZV/K891472.md) | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR | Implant Technology, Inc. | May 2, 1989 | SESE |
| [K890285](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LZV/K890285.md) | PROSTHETIC CEMENT REMOVER | Albert K. Chin | Apr 19, 1989 | SESE |

## Top Applicants

- Origin Medsystems, Inc. — 2 clearances
- Albert K. Chin — 1 clearance
- Implant Technology, Inc. — 1 clearance
- Orthosonics, Ltd. — 1 clearance
- Sonokinetics, Inc. — 1 clearance

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

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