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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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Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-5010
In Commercial Distribution

  • 10889981035136 ()

  • 50mm x 18mm x 10mm, 8 degrees
36-5010

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-5008
In Commercial Distribution

  • 10889981035129 ()

  • 50mm x 18mm x 8mm, 8 degrees
36-5008

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4614
In Commercial Distribution

  • 10889981035099 ()

  • 45mm x 18mm x 14mm, 0 degrees
36-4614

  • Vertebral body prosthesis, non-sterile
45mm x 18mm x 12mm, 0 Deg
SEASPINE ORTHOPEDICS CORPORATION
36-4612
In Commercial Distribution

  • 10889981035082 ()

  • 45mm x 18mm x 12mm, 0 Deg
36-4612

  • Vertebral body prosthesis, non-sterile
45mm x 18mm x 10mm, 0 Deg
SEASPINE ORTHOPEDICS CORPORATION
36-4610
In Commercial Distribution

  • 10889981035075 ()

  • 45mm x 18mm x 10mm, 0 Deg
36-4610

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4608
In Commercial Distribution

  • 10889981035068 ()

  • 45mm x 18mm x 8mm, 0 degrees
36-4608

  • 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
36-4518
Not in Commercial Distribution

  • 10889981035051 ()

  • 45mm x 18mm x 18mm, 8 degrees
36-4518

  • 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
36-4516
Not in Commercial Distribution

  • 10889981035044 ()

  • 45mm x 18mm x 16mm, 8 degrees
36-4516

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4514
In Commercial Distribution

  • 10889981035037 ()

  • 45mm x 18mm x 14mm, 8 degrees
36-4514

  • Vertebral body prosthesis, non-sterile
Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4512
In Commercial Distribution

  • 10889981035020 ()

  • 45mm x 18mm x 12mm, 8 degrees
36-4512

  • Vertebral body prosthesis, non-sterile
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