Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4150](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4150) → KTZ — Caliper

# KTZ · Caliper

_Orthopedic · 21 CFR 888.4150 · Class 1_

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

## Overview

- **Product Code:** KTZ
- **Device Name:** Caliper
- **Regulation:** [21 CFR 888.4150](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4150)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

## 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K921266](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KTZ/K921266.md) | NK MEDICAL MICROMETER, MODEL MC001 | Nk Biotechnical Engineering Co. | Jul 14, 1992 | SESE |
| [K841687](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KTZ/K841687.md) | SKYNDEX ELECTRONIC BODY FAT CALCULA | Caldwell, Justiss & Co., Inc. | Jun 28, 1984 | SESE |
| [K831898](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KTZ/K831898.md) | SCOLIMETER | Dr. Micheal A. Sabia | Jul 19, 1983 | SESE |
| [K820659](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KTZ/K820659.md) | A CALIPER | Twin City Surgical, Inc. | Mar 19, 1982 | SESE |
| [K810116](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KTZ/K810116.md) | ISOROBIC SKINFOLD CALIPER | Fitness Motivation Institute of America | Feb 4, 1981 | SESE |
| [K800363](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KTZ/K800363.md) | PARKE-DAVIS TOTAL KNEE PROSTHESIS | Warner-Lambert Co. | Mar 10, 1980 | SESE |
| [K760521](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KTZ/K760521.md) | TAPE MEASURE | Mcgaw Laboratories | Nov 12, 1976 | SESE |

## Top Applicants

- Caldwell, Justiss & Co., Inc. — 1 clearance
- Dr. Micheal A. Sabia — 1 clearance
- Fitness Motivation Institute of America — 1 clearance
- Mcgaw Laboratories — 1 clearance
- Nk Biotechnical Engineering Co. — 1 clearance

---

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

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