HTJ · Gauge, Depth
Orthopedic · 21 CFR 888.4300 · Class 1
Overview
| Product Code | HTJ |
|---|---|
| Device Name | Gauge, Depth |
| Regulation | 21 CFR 888.4300 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K940480 | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | Acufex Microsurgical, Inc. | Mar 23, 1994 | SESE |
| K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Acufex Microsurgical, Inc. | Dec 29, 1992 | SESE |
| K873191 | ACROMED INTERBODY DEPTH GAUGES | Buckman Co., Inc. | Sep 9, 1987 | SESE |
| K864426 | 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
