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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Solid Polyaxial Screw, 8.50mm x 95mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8595
In Commercial Distribution

  • 10889981016425 ()

  • 8.50mm x 95mm
18-12-8595

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8590
In Commercial Distribution

  • 10889981016418 ()

  • 8.50mm x 90mm
18-12-8590

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 85mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8585
In Commercial Distribution

  • 10889981016401 ()

  • 8.50mm x 85mm
18-12-8585

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 80mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8580
In Commercial Distribution

  • 10889981016395 ()

  • 8.50mm x 80mm
18-12-8580

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8575
In Commercial Distribution

  • 10889981016388 ()

  • 8.50mm x 75mm
18-12-8575

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 70mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8570
In Commercial Distribution

  • 10889981016371 ()

  • 8.50mm x 70mm
18-12-8570

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8565
In Commercial Distribution

  • 10889981016364 ()

  • 8.50mm x 65mm
18-12-8565

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8560
In Commercial Distribution

  • 10889981016357 ()

  • 8.50mm x 60mm
18-12-8560

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8555
In Commercial Distribution

  • 10889981016340 ()

  • 8.50mm x 55mm
18-12-8555

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8550
In Commercial Distribution

  • 10889981016333 ()

  • 8.50mm x 50mm
18-12-8550

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8545
In Commercial Distribution

  • 10889981016326 ()

  • 8.50mm x 45mm
18-12-8545

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8540
In Commercial Distribution

  • 10889981016319 ()

  • 8.50mm x 40mm
18-12-8540

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8535
In Commercial Distribution

  • 10889981016302 ()

  • 8.50mm x 35mm
18-12-8535

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8530
In Commercial Distribution

  • 10889981016296 ()

  • 8.50mm x 30mm
18-12-8530

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8525
In Commercial Distribution

  • 10889981016289 ()

  • 8.50mm x 25mm
18-12-8525

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 8.50mm x 20mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-8520
In Commercial Distribution

  • 10889981016272 ()

  • 8.50mm x 20mm
18-12-8520

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 95mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7595
In Commercial Distribution

  • 10889981016265 ()

  • 7.50mm x 95mm
18-12-7595

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7590
In Commercial Distribution

  • 10889981016258 ()

  • 7.50mm x 90mm
18-12-7590

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 85mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7585
In Commercial Distribution

  • 10889981016241 ()

  • 7.50mm x 85mm
18-12-7585

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 80mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7580
In Commercial Distribution

  • 10889981016234 ()

  • 7.50mm x 80mm
18-12-7580

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7575
In Commercial Distribution

  • 10889981016227 ()

  • 7.50mm x 75mm
18-12-7575

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 70mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7570
In Commercial Distribution

  • 10889981016210 ()

  • 7.50mm x 70mm
18-12-7570

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7565
In Commercial Distribution

  • 10889981016203 ()

  • 7.50mm x 65mm
18-12-7565

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7560
In Commercial Distribution

  • 10889981016197 ()

  • 7.50mm x 60mm
18-12-7560

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7555
In Commercial Distribution

  • 10889981016180 ()

  • 7.50mm x 55mm
18-12-7555

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7550
In Commercial Distribution

  • 10889981016173 ()

  • 7.50mm x 50mm
18-12-7550

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7545
In Commercial Distribution

  • 10889981016166 ()

  • 7.50mm x 45mm
18-12-7545

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7540
In Commercial Distribution

  • 10889981016159 ()

  • 7.50mm x 40mm
18-12-7540

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7535
In Commercial Distribution

  • 10889981016142 ()

  • 7.50mm x 35mm
18-12-7535

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7530
In Commercial Distribution

  • 10889981016135 ()

  • 7.50mm x 30mm
18-12-7530

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7525
In Commercial Distribution

  • 10889981016128 ()

  • 7.50mm x 25mm
18-12-7525

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 7.50mm x 20mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-7520
In Commercial Distribution

  • 10889981016111 ()

  • 7.50mm x 20mm
18-12-7520

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 95mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6595
In Commercial Distribution

  • 10889981016104 ()

  • 6.50mm x 95mm
18-12-6595

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6590
In Commercial Distribution

  • 10889981016098 ()

  • 6.50mm x 90mm
18-12-6590

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 85mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6585
In Commercial Distribution

  • 10889981016081 ()

  • 6.50mm x 85mm
18-12-6585

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 80mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6580
In Commercial Distribution

  • 10889981016074 ()

  • 6.50mm x 80mm
18-12-6580

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6575
In Commercial Distribution

  • 10889981016067 ()

  • 6.50mm x 75mm
18-12-6575

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 70mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6570
In Commercial Distribution

  • 10889981016050 ()

  • 6.50mm x 70mm
18-12-6570

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6565
In Commercial Distribution

  • 10889981016043 ()

  • 6.50mm x 65mm
18-12-6565

  • Bone-screw internal spinal fixation system, non-sterile
Solid Polyaxial Screw, 6.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
18-12-6560
In Commercial Distribution

  • 10889981016036 ()

  • 6.50mm x 60mm
18-12-6560

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