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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 Type Device Class Implantable

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Zuma-L - 10889981097684

Zuma-L Bone Mill, 20mm
SEASPINE ORTHOPEDICS CORPORATION
95-6020
In Commercial Distribution

  • 10889981097684 ()

  • 20mm
95-6020

  • Bone file

Sierra - 10889981094485

20mm Drill
SEASPINE ORTHOPEDICS CORPORATION
95-0135
In Commercial Distribution

  • 10889981094485 ()

  • 20mm
95-0135

  • Surgical screwdriver, reusable

Zuma-C - 10889981087241

20mm Drill
SEASPINE ORTHOPEDICS CORPORATION
92-0189
In Commercial Distribution

  • 10889981087241 ()

  • 20mm
92-0189

  • Manual surgical rotary handpiece, reusable

Balboa - 10889981086565

Awl, 20mm
SEASPINE ORTHOPEDICS CORPORATION
91-9106
In Commercial Distribution

  • 10889981086565 ()

  • 20mm
91-9106

  • Bone awl, reusable

Zuma™ - 10889981037475

Locking Cover, 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
55-6020
In Commercial Distribution

  • 10889981037475 ()

  • 20mm
55-6020

  • Vertebral body prosthesis, non-sterile

Sonoma™ - 10889981050757

Sonoma Anterior Cervical Plate 1 Level Plate, 20mm
SEASPINE ORTHOPEDICS CORPORATION
20-0120
In Commercial Distribution

  • 10889981050757 ()

  • 20mm
20-0120

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ Thoraco-Lumbar - 10889981048310

Thoraco-Lumbar 20mm Bone Screw (BFS-700-20-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0020
In Commercial Distribution

  • 10889981048310 ()

  • 20mm
20-11-0020

  • Spinal fixation plate, non-bioabsorbable

Sierra™ - 10889981043049

Occipital Screw, 20mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-5020
Not in Commercial Distribution

  • 10889981043049 ()

  • 20mm
50-5020

  • Cannulated surgical drill bit, single-use

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

Tether™ - 10889981035426

Plate - 1 Level - 20mm
SEASPINE ORTHOPEDICS CORPORATION
03-10-0120
In Commercial Distribution

  • 10889981035426 ()

  • 20mm
03-10-0120

  • Spinal fixation plate, non-bioabsorbable
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