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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NewPort Double Lead Screw, DIA 7.0 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
61-7060
Not in Commercial Distribution

  • 10889981005511 ()

  • DIA 7.0 x 60mm
61-7060

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
61-7055
Not in Commercial Distribution

  • 10889981005504 ()

  • DIA 7.0 x 55mm
61-7055

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
61-7050
Not in Commercial Distribution

  • 10889981005498 ()

  • DIA 7.0 x 50mm
61-7050

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
61-7045
Not in Commercial Distribution

  • 10889981005481 ()

  • DIA 7.0 x 45mm
61-7045

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
61-7040
Not in Commercial Distribution

  • 10889981005474 ()

  • DIA 7.0 x 40mm
61-7040

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
61-7035
Not in Commercial Distribution

  • 10889981005467 ()

  • DIA 7.0 x 35mm
61-7035

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
61-7030
Not in Commercial Distribution

  • 10889981005450 ()

  • DIA 7.0 x 30mm
61-7030

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
61-7010
Not in Commercial Distribution

  • 10889981005443 ()

  • DIA 7.0 x 110mm
61-7010

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 105mm
SEASPINE ORTHOPEDICS CORPORATION
61-7005
Not in Commercial Distribution

  • 10889981005436 ()

  • DIA 7.0 x 105mm
61-7005

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
61-7000
Not in Commercial Distribution

  • 10889981005429 ()

  • DIA 7.0 x 100mm
61-7000

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
61-6595
Not in Commercial Distribution

  • 10889981005412 ()

  • DIA 6.5 x 95mm
61-6595

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
61-6590
Not in Commercial Distribution

  • 10889981005405 ()

  • DIA 6.5 x 90mm
61-6590

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
61-6585
Not in Commercial Distribution

  • 10889981005399 ()

  • DIA 6.5 x 85mm
61-6585

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
61-6580
Not in Commercial Distribution

  • 10889981005382 ()

  • DIA 6.5 x 80mm
61-6580

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
61-6575
Not in Commercial Distribution

  • 10889981005375 ()

  • DIA 6.5 x 75mm
61-6575

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.5 x 50MM
SEASPINE ORTHOPEDICS CORPORATION
18-8550
Not in Commercial Distribution

  • 10889981004682 ()

  • 8.5 x 50MM
18-8550

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.5 x 45MM
SEASPINE ORTHOPEDICS CORPORATION
18-8545
Not in Commercial Distribution

  • 10889981004675 ()

  • 8.5 x 45MM
18-8545

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.5 x 40MM
SEASPINE ORTHOPEDICS CORPORATION
18-8540
Not in Commercial Distribution

  • 10889981004668 ()

  • 8.5 x 40MM
18-8540

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Polyaxial Screw, 8.5 x 35MM
SEASPINE ORTHOPEDICS CORPORATION
18-8535
Not in Commercial Distribution

  • 10889981004651 ()

  • 8.5 x 35MM
18-8535

  • 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 75mm
SEASPINE ORTHOPEDICS CORPORATION
18-7575
Not in Commercial Distribution

  • 10889981004514 ()

  • Diameter 7.5 x 75mm
18-7575

  • 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 65mm
SEASPINE ORTHOPEDICS CORPORATION
18-7565
Not in Commercial Distribution

  • 10889981004491 ()

  • Diameter 7.5 x 65mm
18-7565

  • 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 55mm
SEASPINE ORTHOPEDICS CORPORATION
18-7555
Not in Commercial Distribution

  • 10889981004477 ()

  • Diameter 7.5 x 55mm
18-7555

  • 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
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