Table, Surgical With Orthopedic Accessories, Ac-Powered
The AC-Powered Surgical Table with Orthopedic Accessories is an electrically powered operating table designed to position patients during orthopedic surgical procedures, accommodating traction, limb support, and specialized attachment devices. It is classified as FDA Class 1 (lowest risk), subject only to general controls including registration and proper labeling. The product code is JEA, regulated under 21 CFR 878.4960, within the General and Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JEA
- Device Class
- FDA class 1
- Regulation Number
- 878.4960
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K953071 | STRYKER COMMAND2 OFFICE CONSOLE | Aug 08, 1995 | Substantially Equivalent | Stryker Instruments |
| K924094 | MEND APC | Mar 30, 1993 | Substantially Equivalent | Mend Technologies, Inc. |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | May 21, 1991 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K911522 | ARTHROBOT(TM) WRIST HOLDER ACCESSORY | Apr 29, 1991 | Substantially Equivalent | Andronic Devices, Ltd. |
| K900290 | SKYTRON MODEL 1100 AND MODEL 142 | Feb 20, 1990 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
| K894789 | DMI 250 SERIES POWER SURGERY TABLE | Aug 29, 1989 | Substantially Equivalent | M.D. Intl., Inc. |
| K881060 | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) | Mar 25, 1988 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K874762 | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY | Dec 10, 1987 | Substantially Equivalent | Andronic Devices, Ltd. |
| K873080 | ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY | Nov 25, 1987 | Substantially Equivalent | Andronic Devices, Ltd. |
| K873079 | ARTHROBOT 100 UPPER LIMB POSITIONER | Nov 25, 1987 | Substantially Equivalent | Andronic Devices, Ltd. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.