Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4600](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4600) → HTH — Protractor

# HTH · Protractor

_Orthopedic · 21 CFR 888.4600 · Class 1_

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

## Overview

- **Product Code:** HTH
- **Device Name:** Protractor
- **Regulation:** [21 CFR 888.4600](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4600)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## 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.

## Classification Rationale

Class I (general 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.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K861576](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH/K861576.md) | SHORTENING OSTEOTOMY GUIDE | Osteotomy Guide Co. | May 12, 1986 | SESE |
| [K841470](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH/K841470.md) | REESE OSTEOTOMY GUIDE SYS | Osteotomy Guide Co. | May 23, 1984 | SESE |
| [K822305](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTH/K822305.md) | ORTHO-LEVEL | Frontier Products | Aug 20, 1982 | SESE |

## Top Applicants

- Osteotomy Guide Co. — 2 clearances
- Frontier Products — 1 clearance

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

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