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 Type Device Class Implantable

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Bone Screw, 5.5mm x 15mm. 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
55-5515
Not in Commercial Distribution

  • 10889981037369 ()

  • 5.5mm Dia x 15mm
55-5515

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm 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
55-3822
Not in Commercial Distribution

  • 10889981037352 ()

  • 38mm x 26mm x 22mm, 8°
55-3822

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm 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
55-3820
Not in Commercial Distribution

  • 10889981037345 ()

  • 38mm x 26mm x 20mm, 8°
55-3820

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm 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
55-3816
In Commercial Distribution

  • 10889981037321 ()

  • 38mm x 26mm x 16mm, 8°
55-3816

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm 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
55-3814
In Commercial Distribution

  • 10889981037314 ()

  • 38mm x 26mm x 14mm, 8°
55-3814

  • Vertebral body prosthesis, non-sterile
Zuma Implant 32mm x 25mm 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
55-3222
Not in Commercial Distribution

  • 10889981037284 ()

  • 32mm x 25mm x 22mm, 8°
55-3222

  • Vertebral body prosthesis, non-sterile
Zuma Implant 32mm x 25mm x 18mm, 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
55-3218
In Commercial Distribution

  • 10889981037260 ()

  • 32mm x 25mm x 18mm, 8°
55-3218

  • 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 26mm x 24mm 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
55-2620
Not in Commercial Distribution

  • 10889981037208 ()

  • 26mm x 24mm x 20mm, 8°
55-2620

  • Vertebral body prosthesis, non-sterile
Zuma Implant 26mm x 24mm x 18mm, 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
55-2618
In Commercial Distribution

  • 10889981037192 ()

  • 26mm x 24mm x 18mm, 8°
55-2618

  • Vertebral body prosthesis, non-sterile
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