Product code JEA— General, Plastic Surgery
ARTHROBOT 100 UPPER LIMB POSITIONER
- Classification name
- Table, Surgical With Orthopedic Accessories, Ac-Powered
- Device class
- Class 1
- Regulation
- 21 CFR 878.4960
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code JEA
FDA has cleared devices under product code JEA between 1987 and 1995, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1995
- 1993
- 1991
- 1990
- 1989
- 1988
- 1987
Top applicants under product code JEA
Recent clearances under product code JEA
- K953071 — STRYKER COMMAND2 OFFICE CONSOLE
- K924094 — MEND APC
- K910736 — JACKSON MULTIPURPOSE OPERATING TABLE
- K911522 — ARTHROBOT(TM) WRIST HOLDER ACCESSORY
- K900290 — SKYTRON MODEL 1100 AND MODEL 142
- K894789 — DMI 250 SERIES POWER SURGERY TABLE
- K881060 — OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)
- K874762 — ARTHROTRACT UPPER LIMB TRACTION ACCESSORY
- K873079 — ARTHROBOT 100 UPPER LIMB POSITIONER
- K873080 — ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY
Data sourced from openFDA. This site is unofficial and independent of the FDA.