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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-C - 10889981087203

12mm Drill
SEASPINE ORTHOPEDICS CORPORATION
92-0182
In Commercial Distribution

  • 10889981087203 ()

  • 12mm
92-0182

  • Manual surgical rotary handpiece, reusable

Sonoma - 10889981087081

12mm Drill, Short
SEASPINE ORTHOPEDICS CORPORATION
92-0161
In Commercial Distribution

  • 10889981087081 ()

  • 12mm
92-0161

  • Orthopaedic implant driver

Sonoma - 10889981086985

12mm Smooth Temporary Fixation Pin
SEASPINE ORTHOPEDICS CORPORATION
92-0151
In Commercial Distribution

  • 10889981086985 ()

  • 12mm
92-0151

  • Orthopaedic bone pin, non-bioabsorbable

Zuma™ - 10889981060442

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

  • 10889981060442 ()

  • 12mm
55-6112

  • Spinal fixation plate, non-bioabsorbable

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™ - 10889981037437

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

Tether™ - 10889981035389

Plate - 1 Level - 12mm
SEASPINE ORTHOPEDICS CORPORATION
03-10-0112
In Commercial Distribution

  • 10889981035389 ()

  • 12mm
03-10-0112

  • Spinal fixation plate, non-bioabsorbable

Vu ePOD™ - 10889981036768

12mm Inserter
SEASPINE ORTHOPEDICS CORPORATION
14-40-0012
In Commercial Distribution

  • 10889981036768 ()

  • 12mm
14-40-0012

  • Orthopaedic implant inserter/extractor, reusable

VuMesh™ - 10889981036553

12mm Sq Non-angled End Cap
SEASPINE ORTHOPEDICS CORPORATION
15-12-1200
In Commercial Distribution

  • 10889981036553 ()

  • 12mm
15-12-1200

  • Vertebral body prosthesis, non-sterile

Coral - 10889981029197

Fixed X-Conn 12mm
SEASPINE ORTHOPEDICS CORPORATION
10-22-0212
In Commercial Distribution

  • 10889981029197 ()

  • 12mm
10-22-0212

  • Bone-screw internal spinal fixation system, non-sterile
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