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
00840343726744	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00840343726737	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00840343726720	FusionMAX	SURGIX MEDICAL LLC	2025-09-10
00842430116261	KIT, HANA SSXT MAQUET 1140 VERSION	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2023-01-17
00842430113093	KIT, HANA SSXT-HIP ARTHROSCOPY UNIT	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2022-05-19
00842430103162	Hana SSXT- AA THA Unit, MOT, EU Rails	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2022-02-14
00842430103155	HANA SSXT- AA THA UNIT, MOT, JP RAILS	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2022-02-14
00842430111365	HANA SSXT- AA THA UNIT REFURB	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2022-02-11
00842430114236	HANA SSXT-HIP ARTHROSCOPY UNIT, LIFEHEALTHCARE IMAGE 777	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2022-02-11
00842430113086	HANA SSXT- AA THA UNIT	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2022-02-11
00842430112553	LATERAL SUPPORT PAD ASSEMBLY	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2021-02-01
00842430101663	TABLE, ProFx, REFURBISHED	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2020-09-09
00842430108914	PATIENT TRANSFER ASSY	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2019-04-02
00842430106484	ProFx TRACTION BOOT ADAPTOR ASSY	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2019-04-02
00842430105920	PIVOTING ARM BOARD ASSY W/OUT PAD	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-11-09
00842430106415	Hana/ProFx LATERAL PERINEAL POST	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-10-17
00842430106125	MTS WELL HIP FIXATION FRAME (8mm)	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-08-24
00842430106477	Hana/ProFx 90DEG PIN AND WIRE HOLDER	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-08-14
00842430106514	Hana/ProFx LOWER LEG SUPPORT	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-08-14
00842430104503	CMBU RADIOLUCENT MAYFIELD ADAPTER	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-05-10
00842430104497	CMBU RADIOLUCENT DORO ADAPTER	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-05-10
00842430106132	MTS WELL HIP FIXATION FRAME (10mm)	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-05-04
00842430105739	Trios/OTS FOOT-END DRAPE HANGER POST	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-05-03
00842430105746	Trios/OTS HEAD-END DRAPE HANGER POST	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-05-03
00842430104541	COUPLER II RADIOLUCENT DORO ADAPTER	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-04-26
00842430105166	Trios/OTS TRACTION EXTENSION LONG	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-04-26
00842430105159	Trios/OTS TRACTION EXTENSION SHORT	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-04-24
00842430105098	PIVOTING ARM BOARD W/TEMPUR 3IN	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-04-18
00842430104404	PIVOTING ARM BOARD W/TEMPUR 2IN	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-04-18
00842430104022	ALUMINUM SIDE RAIL SOCKET	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2018-04-18

Product code JEA

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