Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4300](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4300) → HTJ — Gauge, Depth

# HTJ · Gauge, Depth

_Orthopedic · 21 CFR 888.4300 · Class 1_

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

## Overview

- **Product Code:** HTJ
- **Device Name:** Gauge, Depth
- **Regulation:** [21 CFR 888.4300](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4300)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K940480](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTJ/K940480.md) | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | Acufex Microsurgical, Inc. | Mar 23, 1994 | SESE |
| [K925335](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTJ/K925335.md) | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Acufex Microsurgical, Inc. | Dec 29, 1992 | SESE |
| [K873191](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTJ/K873191.md) | ACROMED INTERBODY DEPTH GAUGES | Buckman Co., Inc. | Sep 9, 1987 | SESE |
| [K864426](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HTJ/K864426.md) | RAYLOR(TM) DEPTH GAUGE | Cedar Surgical, Inc. | Nov 26, 1986 | SESE |

## Top Applicants

- Acufex Microsurgical, Inc. — 2 clearances
- Cedar Surgical, Inc. — 1 clearance
- Buckman Co., Inc. — 1 clearance

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

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