← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K933518

# SYNTHES UNREAMED HUMERAL NAIL (URHN) (K933518)

_Synthes (Usa) · HSB · Mar 14, 1994 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K933518

## Device Facts

- **Applicant:** Synthes (Usa)
- **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md)
- **Decision Date:** Mar 14, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3020
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K933518](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K933518)

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