JEA — Table, Surgical With Orthopedic Accessories, Ac-Powered Class I
FDA product code JEA covers "Table, Surgical With Orthopedic Accessories, Ac-Powered", a Class I medical device regulated under 21 CFR 878.4960. Submissions are reviewed by the General, Plastic Surgery panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JEA
- Device Class
- Class I
- Regulation Number
- 878.4960
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K953071 | stryker instruments | STRYKER COMMAND2 OFFICE CONSOLE | August 8, 1995 |
| K924094 | mend technologies | MEND APC | March 30, 1993 |
| K910736 | orthopedic systems | JACKSON MULTIPURPOSE OPERATING TABLE | May 21, 1991 |
| K911522 | andronic devices | ARTHROBOT(TM) WRIST HOLDER ACCESSORY | April 29, 1991 |
| K900290 | skytron, div. the kmw group | SKYTRON MODEL 1100 AND MODEL 142 | February 20, 1990 |
| K894789 | m.d. intl | DMI 250 SERIES POWER SURGERY TABLE | August 29, 1989 |
| K881060 | orthopedic systems | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) | March 25, 1988 |
| K874762 | andronic devices | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY | December 10, 1987 |
| K873080 | andronic devices | ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY | November 25, 1987 |
| K873079 | andronic devices | ARTHROBOT 100 UPPER LIMB POSITIONER | November 25, 1987 |