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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Polyaxial Screw 4.75mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4555
Not in Commercial Distribution

  • 10889981015053 ()

  • 4.75mm x 55mm
10-12-4555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4545
In Commercial Distribution

  • 10889981015039 ()

  • 4.75mm x 45mm
10-12-4545

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4535
In Commercial Distribution

  • 10889981015015 ()

  • 4.75mm x 35mm
10-12-4535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4525
In Commercial Distribution

  • 10889981014995 ()

  • 4.75mm x 25mm
10-12-4525

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4060
Not in Commercial Distribution

  • 10889981014971 ()

  • 4.00mm x 60mm
10-12-4060

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4050
Not in Commercial Distribution

  • 10889981014957 ()

  • 4.00mm x 50mm
10-12-4050

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4040
In Commercial Distribution

  • 10889981014933 ()

  • 4.00mm x 40mm
10-12-4040

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4035
In Commercial Distribution

  • 10889981014926 ()

  • 4.00mm x 35mm
10-12-4035

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4025
In Commercial Distribution

  • 10889981014902 ()

  • 4.00mm x 25mm
10-12-4025

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 9.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-9590
Not in Commercial Distribution

  • 10889981014889 ()

  • 9.50mm x 90mm
10-11-9590

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