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Mizuho Orthopedic Systems, Inc.

United States·US-MF-000002901

Last updated September 17, 2026

About

Orthopedic and spine surgeons have used Mizuho OSI specialized surgical tables and pressure management products over 40 years for improved patient outcomes.

From the manufacturer's own website. Source

Information

Country: United States
Address: 30031, Ahern Avenue, Union City, United States
Website: www.mizuhosi.com
LinkedIn: linkedin.com/company/mizuho-osi
Facebook: —
Email: [email protected]
Phone: +1 510 429 1500
PRRC Contact: Krina Shah
EUDAMED SRN: US-MF-000002901
FDA FEI Number: 2921578
DUNS Number: —

Catalogue (1370)

Page 1 of 28

Device	Model / Reference	Registries	Class	Status
Heel Cup, Andrews Frame	949-1	EUDAMED	Class I	Active
Operating Table Accessories	5929	EUDAMED	Class I	Active
Drape, Seat, Rectangular, Single	941-1	EUDAMED	Class I	Active
Operating Table Accessories	R05C0133C	EUDAMED	Class I	Active
Ultra Shoulder Positoner 3-Pc Strap Set	5334-1	EUDAMED	Class I	Active
Sleeve, Pad	5324-11	EUDAMED	Class I	Active
Operating Table Accessories	PKIT HANA SUPINE, W/ BOOT, NO HEAD 6/CS	EUDAMED	Class I	Active
Operating Table Accessories	5813-1	EUDAMED	Class I	Active
Pad, Head, Berchtold 8810, 3.5"	694235H	FDA UDI	Class I	Unknown
Balanced Suspension Sling, Size M	751M	FDA UDI	Class I	Active
Aquari Surf Back Skytron 3501b	246-B3502	FDA UDI	Class II	Active
Levó Arm, Refurbished	7887-050R	FDA UDI	Class I	Active
Assembly, Translating, Armboard, Refurb	5376R	FDA UDI	Class I	Active
Lateral Positioner, Refurbished	5300R	FDA UDI	Class I	Active
Assy, Spinal Table Top (500 Lbs) Refurb.	5840-830R	FDA UDI	Class I	Active
Elevator Motor Cable	6977-4140	FDA UDI	Class I	Active
Assy, Head Halter and Chin Cup	339	FDA UDI	Class I	Active
Tempur-Med Stretcher Mattress 26.5 X 78 X 3	69265	FDA UDI	Class I	Active
Avra Head Section 3in Steris 5085	6950853AVH	FDA UDI	Class I	Unknown
Finger Traps, 5 Large, Litegrip	3460L-5	FDA UDI	Class I	Active
Head Support Assy, Refurbished	6977-601R	FDA UDI	Class I	Active
ProFx Spar Lift Assist	6850-7000	FDA UDI	Class I	Active
Adante Hip Arthroscopy Procedure Kit	6895-77	FDA UDI	Class I	Active
Pad, Foot Section 3.5" Skytron 6700/6701	694735F	FDA UDI	Class I	Unknown
Assy, Imaging Table Top, 500 Lbs, Refurb	5840-726R	FDA UDI	Class I	Active
Hana/ProFx Femoral Hook Left	6850-919	FDA UDI	Class I	Active
Aquari Surf Foot 6-Cell 21l Two-V	246-F6000-2V	FDA UDI	Class II	Unknown
Adante FlexLation Spar, Left	6895-70	FDA UDI	Class I	Active
Proaxis Accessory Cart	6988-900	FDA UDI	Class I	Active
Hana Femur Lift Foot Pedal	6875-5003	FDA UDI	Class I	Active
Levó Z Tower, Refurbished	7887-030R	FDA UDI	Class I	Active
Quickconnect Aluminum Skull Clamp	7887-810	FDA UDI	Class I	Unknown
Femur Lift Emergency Handle	6875-602	FDA UDI	Class I	Active
Protectors, Leg Spar Ball Joint, 12/Pr	6856-22	FDA UDI	Class I	Active
Hana/Profx Adult Perineal Post, Refurbished	6850-413R	FDA UDI	Class I	Active
Insite Supine Top With Pad, Refurbished	6844-169R	FDA UDI	Class I	Active
Assy, Spinal Table Top (500 Lbs) Refurb.	5840-831R	FDA UDI	Class I	Active
Pad, Main Table, 5895 Max Access Lat	5895-7133	FDA UDI	Class I	Active
Adante Knee Drape System, Left	6895TKA-L	FDA UDI	Class II	Active
Finger Traps, 5 Medium, Litegrip	3460M-5	FDA UDI	Class I	Active
ZENTRUM i3 US 1V DRVASST	8000-U1-D	FDA UDI	Class I	Unknown
Hana Radiolucent Leg Spar Left	6875-360	FDA UDI	Class I	Active
Clamp, Side Rail, 6in, JP	8000-872-J	FDA UDI	Class I	Unknown
Patient Helper Mounting Sleeve	3423-1	FDA UDI	Class I	Active
Hook And Bow Assembly	6850-123	FDA UDI	Class I	Active
Zentrum ZXT Equipment Cart	6878-500	FDA UDI	Class I	Unknown
Leg Spar, Right	6850-2102	FDA UDI	Class I	Active
Aquari Surface Skytron Herc 6702 3-Pc	246-6702	FDA UDI	Class II	Active
Allegro Imaging Table 120V, 60HZ	6800	FDA UDI	Class II	Active
Aquari Surface Steris 4085, 5085 3-Pc	246-4085	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 27, 2012	Z-1203-2012	—	terminated	Mizuho determined that current labeling of The Coupler II system required revisions after investigation of a complaint.
Jul 29, 2011	Z-0073-2012	—	terminated	Reports of injury related incidents while using the Mizuho OSI Modular Table System.
Mar 30, 2010	Z-0924-2011	—	terminated	Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact.
Feb 28, 2007	Z-0242-2008	—	terminated	Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
Feb 28, 2007	Z-0243-2008	—	terminated	Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
Feb 28, 2007	Z-0241-2008	—	terminated	Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
Feb 14, 2007	Z-0780-2007	—	terminated	Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.