Product code JEA

Device name: Table, Surgical With Orthopedic Accessories, Ac-Powered
Medical specialty: General, Plastic Surgery
Device class: 1
Regulation number: 878.4960
Review panel: SU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K953071	STRYKER COMMAND2 OFFICE CONSOLE	Stryker Instruments	1995-08-08
K924094	MEND APC	Mend Technologies, Inc.	1993-03-30
K910736	JACKSON MULTIPURPOSE OPERATING TABLE	Orthopedic Systems, Inc.	1991-05-21
K911522	ARTHROBOT(TM) WRIST HOLDER ACCESSORY	Andronic Devices, Ltd.	1991-04-29
K900290	SKYTRON MODEL 1100 AND MODEL 142	Skytron, Div. the Kmw Group, Inc.	1990-02-20
K894789	DMI 250 SERIES POWER SURGERY TABLE	M.D. Intl., Inc.	1989-08-29
K881060	OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)	Orthopedic Systems, Inc.	1988-03-25
K874762	ARTHROTRACT UPPER LIMB TRACTION ACCESSORY	Andronic Devices, Ltd.	1987-12-10
K873079	ARTHROBOT 100 UPPER LIMB POSITIONER	Andronic Devices, Ltd.	1987-11-25
K873080	ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY	Andronic Devices, Ltd.	1987-11-25

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00842430116766	WELL LEG SUPPORT, SHORT	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2026-03-31
00842430116735	ADANTE ADAPTER, MAI CLARK SOCKET	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2026-03-31
00840343726737	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00840343726720	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00840343726775	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00840343726768	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00840343726751	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00840343726744	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00842430117121	Adante AX Orthopedic Surgical Platform	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117114	Adante FlexLation Spar, Right	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117107	Adante FlexLation Spar, Left	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117091	Adante Knee Mount, Right	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117084	Adante Knee Mount, Left	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117053	Adante Knee Extension Board	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117046	Adante Pelvic Center Board	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117039	Adante Traction Mount, Right	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117022	Adante Traction Mount, Left	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117008	Adante IntelliTouch Hand Pendant	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430117138	Adante Knee Pad Support Mount, Right	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430116612	Adante Knee Foot Support	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430116605	Adante Femoral Hook Bracket	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430109331	ADANTE TRACTION BOOT, EX LARGE, PAIR	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430109324	ADANTE TRACTION BOOT, LARGE, PAIR	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430109317	ADANTE TRACTION BOOT, SMALL, PAIR	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430109300	ADANTE EXTENDED SADDLE POST	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430109294	ADANTE SADDLE POST	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2025-07-04
00842430116476	Dual Pendant Holder	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2023-01-17
00842430116308	Assembly, Hand Pendant, ProAxis, Refurb	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2023-01-17
00842430108341	DUAL PENDANT HOLDER, 6977, REFURBISHED	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2023-01-17
00842430104527	Coupler II STS Brackets	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-10-17

Product code JEA

Related 510(k) Records#

Related GUDID Devices#