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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12mm Sq Cage X 35mm Long
SEASPINE ORTHOPEDICS CORPORATION
15-10-1235
In Commercial Distribution

  • 10889981036263 ()

  • 12mm x 35mm
15-10-1235

  • Vertebral body prosthesis, non-sterile
12mm Sq Cage X 30mm Long
SEASPINE ORTHOPEDICS CORPORATION
15-10-1230
In Commercial Distribution

  • 10889981036256 ()

  • 12mm x 30mm
15-10-1230

  • Vertebral body prosthesis, non-sterile
12mm Sq Cage X 20mm Long
SEASPINE ORTHOPEDICS CORPORATION
15-10-1220
In Commercial Distribution

  • 10889981036232 ()

  • 12mm x 20mm
15-10-1220

  • Vertebral body prosthesis, non-sterile
12mm Sq Cage X 10mm Long
SEASPINE ORTHOPEDICS CORPORATION
15-10-1210
In Commercial Distribution

  • 10889981036218 ()

  • 12mm x 10mm
15-10-1210

  • Vertebral body prosthesis, non-sterile
55mm x 18mm x 14mm, 0 Deg
SEASPINE ORTHOPEDICS CORPORATION
36-5614
In Commercial Distribution

  • 10889981035334 ()

  • 55mm x 18mm x 14mm, 0 Deg
36-5614

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-5612
In Commercial Distribution

  • 10889981035327 ()

  • 55mm x 18mm x 12mm, 0 degrees
36-5612

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-5610
In Commercial Distribution

  • 10889981035310 ()

  • 55mm x 18mm x 10mm, 0 degrees
36-5610

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-5512
In Commercial Distribution

  • 10889981035266 ()

  • 55mm x 18mm x 12mm, 8 degrees
36-5512

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as a spacer and holding bone graft. The implants have teeth on the superior and inferior surfaces and a central canal for receiving bone graft. These devices are available in a variety of lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All Redondo-L implants are manufactured from PEEK OPTIMA®(polyetheretherketone, ASTM F-2026) with tantalum (ASTM F-560) radiographic wires and/or beads.
SEASPINE ORTHOPEDICS CORPORATION
36-5114
Not in Commercial Distribution

  • 10889981035211 ()

  • 50mm x 18mm x 14mm, 0 degrees
36-5114

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-5110
In Commercial Distribution

  • 10889981035198 ()

  • 50mm x 18mm x 10mm, 0 degrees
36-5110

  • Vertebral body prosthesis, non-sterile
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