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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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Malibu - 10889981007751

Uni-Planar Reduction Screw, 4.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
68-4530
Not in Commercial Distribution

  • 10889981007751 ()

  • 4.5 DIA x 30mm
68-4530

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

Stainless Steel - 10889981114046

Malleable Rod, 400mm
SEASPINE ORTHOPEDICS CORPORATION
25-20-0400
In Commercial Distribution

  • 10889981114046 ()

  • 400mm
25-20-0400

  • Vertebral body prosthesis, non-sterile

Coral - 10889981110932

CoCr Prebent Rod 5.5 x 600mm
SEASPINE ORTHOPEDICS CORPORATION
18-21-0600
In Commercial Distribution

  • 10889981110932 ()

  • 5.5 X 600mm
18-21-0600

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

Coral - 10889981110260

CoCr Prebent Rod 5.5 x 25
SEASPINE ORTHOPEDICS CORPORATION
18-19-0025
In Commercial Distribution

  • 10889981110260 ()

  • 5.5 x 25
18-19-0025

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

Coral - 10889981110253

CoCr Prebent Rod 5.5 x 20
SEASPINE ORTHOPEDICS CORPORATION
18-19-0020
In Commercial Distribution

  • 10889981110253 ()

  • 5.5 x 20
18-19-0020

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

Coral - 10889981110239

CoCr Str. Rod 5.5 x 400
SEASPINE ORTHOPEDICS CORPORATION
18-18-0400
In Commercial Distribution

  • 10889981110239 ()

  • 5.5 x 400
18-18-0400

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

Coral - 10889981105440

Hex-End Straight Rod 5.5 x 600
SEASPINE ORTHOPEDICS CORPORATION
10-25-0600
In Commercial Distribution

  • 10889981105440 ()

  • 5.5 x 600
10-25-0600

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

Coral - 10889981105280

Hex-End Straight Rod 5.5 x 230
SEASPINE ORTHOPEDICS CORPORATION
10-25-0230
In Commercial Distribution

  • 10889981105280 ()

  • 5.5 x 230
10-25-0230

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

NewPort - 10889981125677

NewPort Double Lead Screw, 9.5 x 60mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-9560
In Commercial Distribution

  • 10889981125677 ()

  • 9.5 x 60mm (4mm)
64-9560

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

NewPort - 10889981125660

NewPort Double Lead Screw, 9.5 x 55mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-9555
In Commercial Distribution

  • 10889981125660 ()

  • 9.5 x 55mm (4mm)
64-9555

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

NewPort - 10889981125653

NewPort Double Lead Screw, 9.5 x 50mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-9550
In Commercial Distribution

  • 10889981125653 ()

  • 9.5 x 50mm (4mm)
64-9550

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

NewPort - 10889981125646

NewPort Double Lead Screw, 9.5 x 45mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-9545
In Commercial Distribution

  • 10889981125646 ()

  • 9.5 x 45mm (4mm)
64-9545

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

NewPort - 10889981125639

NewPort Double Lead Screw, 9.5 x 40mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-9540
In Commercial Distribution

  • 10889981125639 ()

  • 9.5 x 40mm (4mm)
64-9540

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

NewPort - 10889981125622

NewPort Double Lead Screw, 9.5 x 35mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-9535
In Commercial Distribution

  • 10889981125622 ()

  • 9.5 x 35mm (4mm)
64-9535

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

NewPort - 10889981125615

NewPort Double Lead Screw, 8.5 x 60mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-8560
In Commercial Distribution

  • 10889981125615 ()

  • 8.5 x 60mm (4mm)
64-8560

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

NewPort - 10889981125608

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 - 10889981125592

NewPort Double Lead Screw, 8.5 x 50mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-8550
In Commercial Distribution

  • 10889981125592 ()

  • 8.5 x 50mm (4mm)
64-8550

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

NewPort - 10889981125585

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 - 10889981125578

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 - 10889981125561

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 - 10889981125554

NewPort Double Lead Screw, 4.75 x 50mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4750
In Commercial Distribution

  • 10889981125554 ()

  • 4.75 x 50mm (4mm)
64-4750

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

NewPort - 10889981125547

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

NewPort - 10889981125530

NewPort Double Lead Screw, 4.75 x 40mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4740
In Commercial Distribution

  • 10889981125530 ()

  • 4.75 x 40mm (4mm)
64-4740

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

NewPort - 10889981125523

NewPort Double Lead Screw, 4.75 x 35mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4735
In Commercial Distribution

  • 10889981125523 ()

  • 4.75 x 35mm (4mm)
64-4735

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

NewPort - 10889981125516

NewPort Double Lead Screw, 4.75 x 30mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4730
In Commercial Distribution

  • 10889981125516 ()

  • 4.75 x 30mm (4mm)
64-4730

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

Coral - 10889981121181

CoCr Str. Rod 5.5 x 500
SEASPINE ORTHOPEDICS CORPORATION
18-18-0500
In Commercial Distribution

  • 10889981121181 ()

  • 5.5 x 500
18-18-0500

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

Coral - 10889981120849

Fixed Screw 7.50mm x 20mm
SEASPINE ORTHOPEDICS CORPORATION
10-10-7520
In Commercial Distribution

  • 10889981120849 ()

  • 7.50mm x 20mm
10-10-7520

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

Coral - 10889981120832

Fixed Screw 6.50mm x 20mm
SEASPINE ORTHOPEDICS CORPORATION
10-10-6520
In Commercial Distribution

  • 10889981120832 ()

  • 6.50mm x 20mm
10-10-6520

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

Coral - 10889981120825

Fixed Screw 5.50mm x 20mm
SEASPINE ORTHOPEDICS CORPORATION
10-10-5520
In Commercial Distribution

  • 10889981120825 ()

  • 5.50mm x 20mm
10-10-5520

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

Malibu - 10889981120320

Cannulated Uni-Planar Dlta Screw DIA 5.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
75-5555
In Commercial Distribution

  • 10889981120320 ()

  • 5.5 x 55mm
75-5555

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