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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Locking Cover, 16mm. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-6016
In Commercial Distribution

  • 10889981037451 ()

  • 16mm
55-6016

  • Vertebral body prosthesis, non-sterile
Locking Cover, 12mm. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-6012
In Commercial Distribution

  • 10889981037437 ()

  • 12mm
55-6012

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 40mm. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-5540
Not in Commercial Distribution

  • 10889981037413 ()

  • 5.5mm Dia x 40mm
55-5540

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm x 10mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-3810
In Commercial Distribution

  • 10889981037291 ()

  • 38mm x 26mm x 10mm, 8°
55-3810

  • Vertebral body prosthesis, non-sterile
Zuma Implant 32mm x 25mm x 20mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-3220
Not in Commercial Distribution

  • 10889981037277 ()

  • 32mm x 25mm x 20mm, 8°
55-3220

  • Vertebral body prosthesis, non-sterile
Zuma Implant 32mm x 25mm x 16mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-3216
In Commercial Distribution

  • 10889981037253 ()

  • 32mm x 25mm x 16mm, 8°
55-3216

  • Vertebral body prosthesis, non-sterile
Zuma Implant 32mm x 25mm x 14mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-3214
In Commercial Distribution

  • 10889981037246 ()

  • 32mm x 25mm x 14mm, 8°
55-3214

  • Vertebral body prosthesis, non-sterile
Zuma Implant 32mm x 25mm x 12mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-3212
In Commercial Distribution

  • 10889981037239 ()

  • 32mm x 25mm x 12mm, 8°
55-3212

  • Vertebral body prosthesis, non-sterile
Zuma Implant 32mm x 25mm x 10mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-3210
In Commercial Distribution

  • 10889981037222 ()

  • 32mm x 25mm x 10mm, 8°
55-3210

  • Vertebral body prosthesis, non-sterile
Zuma Implant 26mm x 24mm x 22mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
SEASPINE ORTHOPEDICS CORPORATION
55-2622
Not in Commercial Distribution

  • 10889981037215 ()

  • 26mm x 24mm x 22mm, 8°
55-2622

  • Vertebral body prosthesis, non-sterile
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