JEB · Table, Surgical With Orthopedic Accessories, Manual
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | JEB |
|---|---|
| Device Name | Table, Surgical With Orthopedic Accessories, Manual |
| Regulation | 21 CFR 878.4950 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K905816 | ORTHOVISION TABLE | American Sterilizer Co. | Mar 6, 1991 | SESE |
| K900405 | SCHOLTEN FRAME | Scholten Surgical Instruments, Inc. | Mar 1, 1990 | SESE |
| K891917 | ORTHO-J, INC. BEK-JS-004 | Ortho-J, Inc. | May 26, 1989 | SESE |
| K891387 | WILLIAMS BELT & BOOT | Arthro-Medic, Inc. | May 23, 1989 | SESE |
| K881101 | K ORTHOPEDIC TABLE | Instrumentation Specialties, Inc. | Apr 6, 1988 | SESE |
| K880263 | OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION | Orthopedic Systems, Inc. | Mar 15, 1988 | SESE |
| K873276 | EXTENSION DEVICE 1416 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| K873275 | EXTENSION TABLE 1417 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| K873274 | PLASTER TABLE 1418 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| K873273 | ORTHOPAEDIC TABLE 1420 | Stierlen-Maquet AG | Sep 17, 1987 | SESE |
| K781082 | CAST BLOCK | Orthopedic Equipment Co., Inc. | Jul 7, 1978 | SESE |
| K772321 | ARTHROSTRESS | Mtd, Inc. | Jan 3, 1978 | SESE |
| K771020 | SPINAL SURGERY FRAME | Orthopedic Systems, Inc. | Jun 17, 1977 | SESE |
Top Applicants
- Stierlen-Maquet AG — 4 clearances
- Orthopedic Systems, Inc. — 2 clearances
- Scholten Surgical Instruments, Inc. — 1 clearance
- Orthopedic Equipment Co., Inc. — 1 clearance
- Ortho-J, Inc. — 1 clearance
