← Product Code [JXS](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JXS) · K822371

# MICRO WORKTABLE (K822371)

_Treace Medical, Inc. · JXS · Sep 9, 1982 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JXS/K822371

## Device Facts

- **Applicant:** Treace Medical, Inc.
- **Product Code:** [JXS](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JXS.md)
- **Decision Date:** Sep 9, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3540
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTM punch; wire cutting scissors; and ossicular finger vise.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JXS/K822371](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JXS/K822371)

**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