Mizuho Orthopedic Systems Inc
Union City, CA, US
MIZUHO ORTHOPEDIC SYSTEMS, INC. appears in FDA device records in Union City, CA. FDA records list 95 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Mizuho Orthopedic Systems Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Mizuho OSIenforcement report, recall
- Orthopedic Systems, Inc.510(k), recall
510(k) clearance history
Showing 50 of 95FDA records hold 95 510(k) clearances for Mizuho Orthopedic Systems Inc between 1977 and 1996. The busiest year on record is 1987, with 21. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 4 |
| 1979 | 1 |
| 1980 | 4 |
| 1981 | 1 |
| 1982 | 12 |
| 1983 | 6 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 6 |
| 1987 | 21 |
| 1988 | 15 |
| 1989 | 12 |
| 1990 | 3 |
| 1991 | 3 |
| 1992 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | LXH | Substantially Equivalent | |
| K920256 | SPINE MOTION ANALYZER WITH EMG | KQX | Substantially Equivalent | |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | JEA | Substantially Equivalent | |
| K910031 | PARK CITY SHOULDER POSITIONER | FWZ | Substantially Equivalent | |
| K903938 | C FIT CUP | JDI | Substantially Equivalent for Some Indications | |
| K892503 | NUFFIELD TOTAL KNEE | JWH | Substantially Equivalent for Some Indications | |
| K896678 | SILICONE PLUG | HRX | Substantially Equivalent | |
| K894283 | COMPREHENSIVE SPINE MOTION ANALYZER | KQX | Substantially Equivalent | |
| K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION | JDI | Substantially Equivalent for Some Indications | |
| K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM | LWJ | Substantially Equivalent | |
| K895219 | CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM | HWC | Substantially Equivalent | |
| K895218 | CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM | HWC | Substantially Equivalent | |
| K895217 | CORTICAL SCREW | HWC | Substantially Equivalent | |
| K894249 | UNIVERSAL CEMENTED CUP | JDI | Substantially Equivalent | |
| K891539 | CTI II STRAIGHT STEM | LWJ | Substantially Equivalent | |
| K891903 | COHN TARGETEER | LXH | Substantially Equivalent | |
| K890187 | THE C-S DISTRACTION ROD ASSEMBLY | KWP | Substantially Equivalent | |
| K890185 | C-S IMPACTOR | LYP | Substantially Equivalent | |
| K875130 | BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS | HRX | Substantially Equivalent | |
| K884483 | CRUCIOMETER | JZE | Substantially Equivalent | |
| K884641 | BOVAC SMOKE COLLECTOR | GEI | Substantially Equivalent | |
| K883457 | ASST-3000 SPINAL SURGERY TABLE | FWY | Substantially Equivalent | |
| K881511 | FIXATOR PIN (EXTERNAL) | JDW | Substantially Equivalent | |
| K881289 | CORIN BIPOLAR PROSTHESIS | KWY | Substantially Equivalent | |
| K881288 | CORIN MODULAR MOORE STEM | LWJ | Substantially Equivalent | |
| K880203 | HERMAN CANNULA SET | HRX | Substantially Equivalent | |
| K881060 | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) | JEA | Substantially Equivalent | |
| K880264 | BONE SUTURE FIXATION DEVICE | HXY | Substantially Equivalent for Some Indications | |
| K880263 | OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION | JEB | Substantially Equivalent | |
| K880253 | BLAKEMORE RETAINER | FEF | Substantially Equivalent | |
| K880265 | WEHBE ARM HOLDER | FWZ | Substantially Equivalent | |
| K874616 | MOORE HIP PROSTHESIS FENESTRATED STEM | JDI | Substantially Equivalent | |
| K874599 | MOORE HIP PROSTHESIS SOLID STEM | JDI | Substantially Equivalent | |
| K875235 | ISOKINETIC SYSTEM, TESTING AND EVALUATION | IKK | Substantially Equivalent | |
| K873660 | ROPER-TUKE ELBOW | JDB | Substantially Equivalent for Some Indications | |
| K873626 | FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM | JDI | Substantially Equivalent for Some Indications | |
| K873627 | CTI STRAIGHT STEM | JDG | Substantially Equivalent | |
| K874617 | THOMPSON HIP PROSTHESIS | JDG | Substantially Equivalent | |
| K874130 | TITANIUM BONE SCREWS | HWC | Substantially Equivalent | |
| K873632 | HI-NEK TOTAL HIP | JDI | Substantially Equivalent | |
| K874300 | AESTHESIOMETER | GWI | Substantially Equivalent | |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | HWT | Substantially Equivalent | |
| K871287 | ORTHOPEDIC DRILL GUIDE | HSZ | Substantially Equivalent | |
| K871225 | HAND SURGERY TABLE EXTENSION | FWZ | Substantially Equivalent | |
| K870105 | INFANT CAST TABLE | Substantially Equivalent | ||
| K870104 | RADIOLUCENT TABLE EXTENSION | FWZ | Substantially Equivalent | |
| K870101 | CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION | FWZ | Substantially Equivalent | |
| K870099 | PIVOTING SURGICAL ARM BOARDS | Substantially Equivalent | ||
| K870098 | LITHOTOMY HOLDERS | FWZ | Substantially Equivalent | |
| K870125 | EXTREMITY ELEVATOR | HST | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2921578 | 2921578 | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 30031 AHERN AVE, UNION CITY, CA 94587 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYPAccessories, Fixation, Spinal Interlaminal
- KNOAccessories, Wheelchair
- HSTApparatus, Traction, Non-Powered
- KWPAppliance, Fixation, Spinal Interlaminal
- EAJApron, Leaded
- HRXArthroscope
- FNJBed, Manual
- KMEBedding, Disposable, Medical
- HXYBrace, Drill
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- LGFComponent, Cast
- ISHComponent, External, Limb, Ankle/Foot
- KQZComponent, Traction, Non-Invasive
- IPMCover, Limb
- IMPCushion, Wheelchair
- FMRDevice, Transfer, Patient, Manual
- GWIDiscriminator, Two-Point
- PUIDrape, Surgical, Exempt
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- KQXGoniometer, Ac-Powered
- HSSHalter, Head, Traction
- LGGInstrument, Cast Application/Removal, Manual
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- ITQJoint, Knee, External Brace
- FNMMattress, Air Flotation, Alternating Pressure
- GEYMotor, Surgical Instrument, Ac-Powered
- FWZOperating Room Accessories Table Tray
- LXHOrthopedic Manual Surgical Instrument
- JDWPin, Fixation, Threaded
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- FMPProtector, Skin Pressure
- HTHProtractor
- FMQRestraint, Protective
- HWCScrew, Fixation, Bone
- ILISling, Arm
- FYHSplint, Extremity, Noninflatable, External, Sterile
- ILHSplint, Hand, And Components
- IQMSplint, Temporary Training
- HSPSplint, Traction
- JZESpoon, Ear
- FOXStand, Infusion
- CCXSupport, Patient Position
- IKKSystem, Isokinetic Testing And Evaluation
- FQOTable, Operating-Room, Ac-Powered
- FSETable, Operating-Room, Manual
- FWYTable, Operating-Room, Non-Electrical
- KXJTable, Radiologic
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered
- JEBTable, Surgical With Orthopedic Accessories, Manual
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- HAXTong, Skull For Traction
- FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1573-2022 | HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 | One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number. | Class II | Open, Classified | |
| Z-1293-2021 | Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations. | There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure. | Class II | Open, Classified | |
| Z-0091-2021 | Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery. | Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism | Class II | Terminated | |
| Z-1867-2017 | 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements. | Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury. | Class II | Terminated | |
| Z-0792-2016 | Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized. | Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone. | Class II | Terminated | |
| Z-0810-2013 | Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar. | Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top. | Class II | Terminated | |
| Z-1203-2012 | Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc. | Mizuho determined that current labeling of The Coupler II system required revisions after investigation of a complaint. | Terminated | ||
| Z-0073-2012 | Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient. | Reports of injury related incidents while using the Mizuho OSI Modular Table System. | Terminated | ||
| Z-0924-2011 | Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA. | 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. | Terminated | ||
| Z-0243-2008 | OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included) | Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. | Terminated | ||
| Z-0242-2008 | OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Orthopedic Systems, Inc., Union City, CA | Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. | Terminated | ||
| Z-0241-2008 | OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA | Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. | Terminated | ||
| Z-0780-2007 | Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain