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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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Zuma™ - 10889981037451

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

Zuma™ - 10889981037444

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

Zuma™ - 10889981037413

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™ - 10889981037383

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

Zuma™ - 10889981037154

Zuma Implant, 26mm x 24mm 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
55-2610
In Commercial Distribution

  • 10889981037154 ()

  • 26mm x 24mm x 10mm, 8°
55-2610

  • Vertebral body prosthesis, non-sterile

Zuma™ - 10889981037550

Plate Trial, 22mm. Zuma™ Trials are used to determine the appropriate Zuma implant size.
SEASPINE ORTHOPEDICS CORPORATION
95-5022
In Commercial Distribution

  • 10889981037550 ()

  • 22mm
95-5022

  • Spinal implant trial

Zuma™ - 10889981037543

Plate Trial, 20mm. Zuma™ Trials are used to determine the appropriate Zuma implant size.
SEASPINE ORTHOPEDICS CORPORATION
95-5020
In Commercial Distribution

  • 10889981037543 ()

  • 20mm
95-5020

  • Spinal implant trial

Zuma™ - 10889981037512

Plate Trial, 14mm. Zuma™ Trials are used to determine the appropriate Zuma implant size.
SEASPINE ORTHOPEDICS CORPORATION
95-5014
In Commercial Distribution

  • 10889981037512 ()

  • 14mm
95-5014

  • Spinal implant trial

Zuma™ - 10889981037505

Plate Trial, 12mm. Zuma™ Trials are used to determine the appropriate Zuma implant size.
SEASPINE ORTHOPEDICS CORPORATION
95-5012
In Commercial Distribution

  • 10889981037505 ()

  • 12mm
95-5012

  • Spinal implant trial

Zuma™ - 10889981037499

Plate Trial, 10mm. Zuma™ Trials are used to determine the appropriate Zuma implant size.
SEASPINE ORTHOPEDICS CORPORATION
95-5010
In Commercial Distribution

  • 10889981037499 ()

  • 10mm
95-5010

  • Spinal implant trial
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