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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LP Locking Cover, 12mm
SEASPINE ORTHOPEDICS CORPORATION
55-6112
In Commercial Distribution

  • 10889981060442 ()

  • 12mm
55-6112

  • Spinal fixation plate, non-bioabsorbable
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
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
Zuma-L Locking Cover, 12mm
SEASPINE ORTHOPEDICS CORPORATION
56-9012
In Commercial Distribution

  • 10889981059859 ()

  • 12mm
56-9012

  • Spinal fixation plate, non-bioabsorbable
Lateral Paddle Distractor, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-6272
In Commercial Distribution

  • 10889981098322 ()

  • 12mm
95-6272

  • Orthopaedic surgical distractor, internal
Curved Paddle Shaver, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-6242
In Commercial Distribution

  • 10889981098155 ()

  • 12mm
95-6242

  • Bone file
Parallel Paddle Shaver, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-6222
In Commercial Distribution

  • 10889981098070 ()

  • 12mm
95-6222

  • Bone file
Zuma-C Locking Cover, 12mm
SEASPINE ORTHOPEDICS CORPORATION
57-9212
In Commercial Distribution

  • 10889981053543 ()

  • 12mm
57-9212

  • Vertebral body prosthesis, non-sterile
Zuma-C Locking Cover, 12mm
SEASPINE ORTHOPEDICS CORPORATION
57-9012
In Commercial Distribution

  • 10889981053475 ()

  • 12mm
57-9012

  • Vertebral body prosthesis, non-sterile
12mm Drill
SEASPINE ORTHOPEDICS CORPORATION
92-0182
In Commercial Distribution

  • 10889981087203 ()

  • 12mm
92-0182

  • Manual surgical rotary handpiece, reusable
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