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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Uni-Planar Screw, 5.0 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
67-5040
Not in Commercial Distribution

  • 10889981007126 ()

  • 5.0 DIA x 40mm
67-5040

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 5.0 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
67-5035
Not in Commercial Distribution

  • 10889981007119 ()

  • 5.0 DIA x 35mm
67-5035

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 5.0 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
67-5025
Not in Commercial Distribution

  • 10889981007096 ()

  • 5.0 DIA x 25mm
67-5025

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.5 x 70MM
SEASPINE ORTHOPEDICS CORPORATION
18-8570
Not in Commercial Distribution

  • 10889981004729 ()

  • 8.5 x 70MM
18-8570

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.5 x 30MM
SEASPINE ORTHOPEDICS CORPORATION
18-8530
Not in Commercial Distribution

  • 10889981004644 ()

  • 8.5 x 30MM
18-8530

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 80MM
SEASPINE ORTHOPEDICS CORPORATION
18-8080
Not in Commercial Distribution

  • 10889981004637 ()

  • 8.0 x 80MM
18-8080

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 75MM
SEASPINE ORTHOPEDICS CORPORATION
18-8075
Not in Commercial Distribution

  • 10889981004620 ()

  • 8.0 x 75MM
18-8075

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 70MM
SEASPINE ORTHOPEDICS CORPORATION
18-8070
Not in Commercial Distribution

  • 10889981004613 ()

  • 8.0 x 70MM
18-8070

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 65MM
SEASPINE ORTHOPEDICS CORPORATION
18-8065
Not in Commercial Distribution

  • 10889981004606 ()

  • 8.0 x 65MM
18-8065

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 60MM
SEASPINE ORTHOPEDICS CORPORATION
18-8060
Not in Commercial Distribution

  • 10889981004590 ()

  • 8.0 x 60MM
18-8060

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 55MM
SEASPINE ORTHOPEDICS CORPORATION
18-8055
Not in Commercial Distribution

  • 10889981004583 ()

  • 8.0 x 55MM
18-8055

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 50MM
SEASPINE ORTHOPEDICS CORPORATION
18-8050
Not in Commercial Distribution

  • 10889981004576 ()

  • 8.0 x 50MM
18-8050

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 45MM
SEASPINE ORTHOPEDICS CORPORATION
18-8045
Not in Commercial Distribution

  • 10889981004569 ()

  • 8.0 x 45MM
18-8045

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 40MM
SEASPINE ORTHOPEDICS CORPORATION
18-8040
Not in Commercial Distribution

  • 10889981004552 ()

  • 8.0 x 40MM
18-8040

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 35MM
SEASPINE ORTHOPEDICS CORPORATION
18-8035
Not in Commercial Distribution

  • 10889981004545 ()

  • 8.0 x 35MM
18-8035

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.0 x 30MM
SEASPINE ORTHOPEDICS CORPORATION
18-8030
Not in Commercial Distribution

  • 10889981004538 ()

  • 8.0 x 30MM
18-8030

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
18-7580
Not in Commercial Distribution

  • 10889981004521 ()

  • Diameter 7.5 x 80mm
18-7580

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
18-7570
Not in Commercial Distribution

  • 10889981004507 ()

  • Diameter 7.5 x 70mm
18-7570

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
18-7560
Not in Commercial Distribution

  • 10889981004484 ()

  • Diameter 7.5 x 60mm
18-7560

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
18-7550
Not in Commercial Distribution

  • 10889981004460 ()

  • Diameter 7.5 x 50mm
18-7550

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 7.5mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
18-7545
In Commercial Distribution

  • 10889981004453 ()

  • Diameter 7.5 x 45mm
18-7545

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 7.5mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
18-7540
In Commercial Distribution

  • 10889981004446 ()

  • Diameter 7.5 x 40mm
18-7540

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
18-7535
Not in Commercial Distribution

  • 10889981004439 ()

  • Diameter 7.5 x 35mm
18-7535

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
18-7530
Not in Commercial Distribution

  • 10889981004422 ()

  • Diameter 7.5 x 30mm
18-7530

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.0 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
18-7070
Not in Commercial Distribution

  • 10889981004415 ()

  • Diameter 7.0 x 70mm
18-7070

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.0 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
18-7065
Not in Commercial Distribution

  • 10889981004408 ()

  • Diameter 7.0 x 65mm
18-7065

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.0 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
18-7060
Not in Commercial Distribution

  • 10889981004392 ()

  • Diameter 7.0 x 60mm
18-7060

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.0 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
18-7055
Not in Commercial Distribution

  • 10889981004385 ()

  • Diameter 7.0 x 55mm
18-7055

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.0 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
18-7050
Not in Commercial Distribution

  • 10889981004378 ()

  • Diameter 7.0 x 50mm
18-7050

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, Diameter 7.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
18-7045
Not in Commercial Distribution

  • 10889981004361 ()

  • Diameter 7.0 x 45mm
18-7045

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