← Product Code [JDX](/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX) · K002484

# EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (K002484)

_Electro Medical Systems SA · JDX · Oct 4, 2000 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K002484

## Device Facts

- **Applicant:** Electro Medical Systems SA
- **Product Code:** [JDX](/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX.md)
- **Decision Date:** Oct 4, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.4580
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K002484](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K002484)

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