Table, Surgical With Orthopedic Accessories, Manual
The Manual Surgical Table with Orthopedic Accessories is a non-powered, manually adjustable operating table equipped with attachments to support patient positioning during orthopedic surgical procedures such as fracture fixation or joint replacement. It is classified as FDA Class 1 (lowest risk), governed solely by general controls. The product code is JEB, regulated under 21 CFR 878.4950, within the General and Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JEB
- Device Class
- FDA class 1
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K905816 | ORTHOVISION TABLE | Mar 06, 1991 | Substantially Equivalent | American Sterilizer Co. |
| K900405 | SCHOLTEN FRAME | Mar 01, 1990 | Substantially Equivalent | Scholten Surgical Instruments, Inc. |
| K891917 | ORTHO-J, INC. BEK-JS-004 | May 26, 1989 | Substantially Equivalent | Ortho-J, Inc. |
| K891387 | WILLIAMS BELT & BOOT | May 23, 1989 | Substantially Equivalent | Arthro-Medic, Inc. |
| K881101 | K ORTHOPEDIC TABLE | Apr 06, 1988 | Substantially Equivalent | Instrumentation Specialties, Inc. |
| K880263 | OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION | Mar 15, 1988 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K873276 | EXTENSION DEVICE 1416 | Sep 17, 1987 | Substantially Equivalent | Stierlen-Maquet AG |
| K873275 | EXTENSION TABLE 1417 | Sep 17, 1987 | Substantially Equivalent | Stierlen-Maquet AG |
| K873274 | PLASTER TABLE 1418 | Sep 17, 1987 | Substantially Equivalent | Stierlen-Maquet AG |
| K873273 | ORTHOPAEDIC TABLE 1420 | Sep 17, 1987 | Substantially Equivalent | Stierlen-Maquet AG |
| K781082 | CAST BLOCK | Jul 07, 1978 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
| K772321 | ARTHROSTRESS | Jan 03, 1978 | Substantially Equivalent | Mtd, Inc. |
| K771020 | SPINAL SURGERY FRAME | Jun 17, 1977 | Substantially Equivalent | Orthopedic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.