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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, 14mm. 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
55-6014
In Commercial Distribution

  • 10889981037444 ()

  • 14mm
55-6014

  • Vertebral body prosthesis, non-sterile
Locking Cover, 10mm. 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
55-6010
In Commercial Distribution

  • 10889981037420 ()

  • 10mm
55-6010

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 35mm. 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
55-5535
Not in Commercial Distribution

  • 10889981037406 ()

  • 5.5mm Dia x 35mm
55-5535

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 30mm. 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
55-5530
In Commercial Distribution

  • 10889981037390 ()

  • 5.5mm Dia x 30mm
55-5530

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 25mm. 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
55-5525
In Commercial Distribution

  • 10889981037383 ()

  • 5.5mm Dia x 25mm
55-5525

  • Vertebral body prosthesis, non-sterile
Bone Screw, 5.5mm x 20mm. 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
55-5520
In Commercial Distribution

  • 10889981037376 ()

  • 5.5mm Dia x 20mm
55-5520

  • Vertebral body prosthesis, non-sterile
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
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