← Product Code [HTH](/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH) · K861576

# SHORTENING OSTEOTOMY GUIDE (K861576)

_Osteotomy Guide Co. · HTH · May 12, 1986 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH/K861576

## Device Facts

- **Applicant:** Osteotomy Guide Co.
- **Product Code:** [HTH](/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH.md)
- **Decision Date:** May 12, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.4600
- **Device Class:** Class 1
- **Review Panel:** Orthopedic

## Regulatory Identification

A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH/K861576](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH/K861576)

**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