← Product Code [JDX](/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX) · K930109

# KOMET MEDICAL SURGICAL POWER ACCESORIES (K930109)

_Brassler USA · JDX · Aug 25, 1993 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K930109

## Device Facts

- **Applicant:** Brassler USA
- **Product Code:** [JDX](/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX.md)
- **Decision Date:** Aug 25, 1993
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K930109](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX/K930109)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com