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 2 Implant
SEASPINE ORTHOPEDICS CORPORATION
NWP2IMP
In Commercial Distribution

  • 10889983163066 ()
NWP2IMP

  • Instrument tray, reusable
NewPort Double Lead Screw, 8.5 x 55mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-8555
In Commercial Distribution

  • 10889981125608 ()

  • 8.5 x 55mm (4mm)
64-8555

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, 8.5 x 45mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-8545
In Commercial Distribution

  • 10889981125585 ()

  • 8.5 x 45mm (4mm)
64-8545

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, 8.5 x 40mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-8540
In Commercial Distribution

  • 10889981125578 ()

  • 8.5 x 40mm (4mm)
64-8540

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, 8.5 x 35mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-8535
In Commercial Distribution

  • 10889981125561 ()

  • 8.5 x 35mm (4mm)
64-8535

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, 4.75 x 45mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4745
In Commercial Distribution

  • 10889981125547 ()

  • 4.75 x 45mm (4mm)
64-4745

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
63-7580
In Commercial Distribution

  • 10889981006969 ()

  • Diameter 7.5 x 80mm
63-7580

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
63-7575
Not in Commercial Distribution

  • 10889981006952 ()

  • Diameter 7.5 x 75mm
63-7575

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
63-7570
In Commercial Distribution

  • 10889981006945 ()

  • Diameter 7.5 x 70mm
63-7570

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
63-7565
In Commercial Distribution

  • 10889981006938 ()

  • Diameter 7.5 x 65mm
63-7565

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.0 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
63-7060
Not in Commercial Distribution

  • 10889981006792 ()

  • Diameter 7.0 x 60mm
63-7060

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.0 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
63-7050
Not in Commercial Distribution

  • 10889981006778 ()

  • Diameter 7.0 x 50mm
63-7050

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
63-7045
Not in Commercial Distribution

  • 10889981006761 ()

  • Diameter 7.0 x 45mm
63-7045

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
63-7040
Not in Commercial Distribution

  • 10889981006754 ()

  • Diameter 7.0 x 40mm
63-7040

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.0 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
63-7035
Not in Commercial Distribution

  • 10889981006747 ()

  • Diameter 7.0 x 35mm
63-7035

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
63-7030
Not in Commercial Distribution

  • 10889981006730 ()

  • Diameter 7.0 x 30mm
63-7030

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 7.0 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
63-7025
Not in Commercial Distribution

  • 10889981006723 ()

  • Diameter 7.0 x 25mm
63-7025

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
63-6595
Not in Commercial Distribution

  • 10889981006716 ()

  • Diameter 6.5 x 95mm
63-6595

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
63-6590
Not in Commercial Distribution

  • 10889981006709 ()

  • Diameter 6.5 x 90mm
63-6590

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
63-6585
Not in Commercial Distribution

  • 10889981006693 ()

  • Diameter 6.5 x 85mm
63-6585

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
63-6580
Not in Commercial Distribution

  • 10889981006686 ()

  • Diameter 6.5 x 80mm
63-6580

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
63-6575
Not in Commercial Distribution

  • 10889981006679 ()

  • Diameter 6.5 x 75mm
63-6575

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
63-6570
Not in Commercial Distribution

  • 10889981006662 ()

  • Diameter 6.5 x 70mm
63-6570

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
63-6565
Not in Commercial Distribution

  • 10889981006655 ()

  • Diameter 6.5 x 65mm
63-6565

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
63-6560
Not in Commercial Distribution

  • 10889981006648 ()

  • Diameter 6.5 x 60mm
63-6560

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
63-6555
In Commercial Distribution

  • 10889981006631 ()

  • Diameter 6.5 x 55mm
63-6555

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
63-6550
In Commercial Distribution

  • 10889981006624 ()

  • Diameter 6.5 x 50mm
63-6550

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
63-6545
In Commercial Distribution

  • 10889981006617 ()

  • Diameter 6.5 x 45mm
63-6545

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
63-6540
In Commercial Distribution

  • 10889981006600 ()

  • Diameter 6.5 x 40mm
63-6540

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Diameter 6.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
63-6535
In Commercial Distribution

  • 10889981006594 ()

  • Diameter 6.5 x 35mm
63-6535

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