Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950) → JEB — Table, Surgical With Orthopedic Accessories, Manual

# JEB · Table, Surgical With Orthopedic Accessories, Manual

_General, Plastic Surgery · 21 CFR 878.4950 · Class 1_

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

## Overview

- **Product Code:** JEB
- **Device Name:** Table, Surgical With Orthopedic Accessories, Manual
- **Regulation:** [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

## 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 § 878.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K905816](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K905816.md) | ORTHOVISION TABLE | American Sterilizer Co. | Mar 6, 1991 | SESE |
| [K900405](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K900405.md) | SCHOLTEN FRAME | Scholten Surgical Instruments, Inc. | Mar 1, 1990 | SESE |
| [K891917](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K891917.md) | ORTHO-J, INC. BEK-JS-004 | Ortho-J, Inc. | May 26, 1989 | SESE |
| [K891387](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K891387.md) | WILLIAMS BELT & BOOT | Arthro-Medic, Inc. | May 23, 1989 | SESE |
| [K881101](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K881101.md) | K ORTHOPEDIC TABLE | Instrumentation Specialties, Inc. | Apr 6, 1988 | SESE |
| [K880263](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K880263.md) | OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION | Orthopedic Systems, Inc. | Mar 15, 1988 | SESE |
| [K873276](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K873276.md) | EXTENSION DEVICE 1416 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| [K873275](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K873275.md) | EXTENSION TABLE 1417 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| [K873274](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K873274.md) | PLASTER TABLE 1418 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| [K873273](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K873273.md) | ORTHOPAEDIC TABLE 1420 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| [K781082](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K781082.md) | CAST BLOCK | Orthopedic Equipment Co., Inc. | Jul 7, 1978 | SESE |
| [K772321](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K772321.md) | ARTHROSTRESS | Mtd, Inc. | Jan 3, 1978 | SESE |
| [K771020](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEB/K771020.md) | SPINAL SURGERY FRAME | Orthopedic Systems, Inc. | Jun 17, 1977 | SESE |

## Top Applicants

- Stierlen-Maquet AG — 4 clearances
- Orthopedic Systems, Inc. — 2 clearances
- American Sterilizer Co. — 1 clearance
- Arthro-Medic, Inc. — 1 clearance
- Instrumentation Specialties, Inc. — 1 clearance

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

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