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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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SeaSpine NewPort Spinal System - 10889981138813

Newport 4.75 X 50mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4750
In Commercial Distribution

  • 10889981138813 ()

  • 4.75 X 50mm
61-4750

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

SeaSpine NewPort Spinal System - 10889981138806

Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

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

SeaSpine NewPort Spinal System - 10889981138790

Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

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

SeaSpine NewPort Spinal System - 10889981138783

Newport 4.75 X 35mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4735
In Commercial Distribution

  • 10889981138783 ()

  • 4.75 X 35mm
61-4735

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

SeaSpine NewPort Spinal System - 10889981138776

Newport 4.75 X 30mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4730
In Commercial Distribution

  • 10889981138776 ()

  • 4.75 X 30mm
61-4730

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

UCR - 10889981062941

BULLET NOSE ROD, 5.5 x 150mm
SEASPINE ORTHOPEDICS CORPORATION
10-3150
In Commercial Distribution

  • 10889981062941 ()

  • 5.5 x 150mm
10-3150

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

UCR - 10889981062699

CAP, 8MM
SEASPINE ORTHOPEDICS CORPORATION
10-0028
In Commercial Distribution

  • 10889981062699 ()

  • 8MM
10-0028

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

UCR - 10889981062675

SETSCREW, 8MM
SEASPINE ORTHOPEDICS CORPORATION
10-0018
In Commercial Distribution

  • 10889981062675 ()

  • 8MM
10-0018

  • 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

Newport - 10889981120306

NewPort Double Lead Screw, DIA 5.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
61-5560
In Commercial Distribution

  • 10889981120306 ()

  • 5.5 x 60mm
61-5560

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

Newport - 10889981120283

NewPort MIS Rod 2, 85mm
SEASPINE ORTHOPEDICS CORPORATION
60-0585
In Commercial Distribution

  • 10889981120283 ()

  • 85mm
60-0585

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

Newport - 10889981120276

Newport MIS Rod 2, 30mm
SEASPINE ORTHOPEDICS CORPORATION
60-0530
In Commercial Distribution

  • 10889981120276 ()

  • 30mm
60-0530

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

Newport - 10889981120269

85mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0485
In Commercial Distribution

  • 10889981120269 ()

  • 85mm
60-0485

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

Newport - 10889981120252

30mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0430
In Commercial Distribution

  • 10889981120252 ()

  • 30mm
60-0430

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

Newport - 10889981120245

85mm NewPort MIS Cap/Rod Combo 2
SEASPINE ORTHOPEDICS CORPORATION
60-0385
In Commercial Distribution

  • 10889981120245 ()

  • 85mm
60-0385

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

Newport - 10889981120238

30mm NewPort MIS Cap/Rod Combo 2
SEASPINE ORTHOPEDICS CORPORATION
60-0330
In Commercial Distribution

  • 10889981120238 ()

  • 30mm
60-0330

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

Newport - 10889981120214

65mm NewPort MIS Cap/Rod Combo
SEASPINE ORTHOPEDICS CORPORATION
60-0265
In Commercial Distribution

  • 10889981120214 ()

  • 65mm
60-0265

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

Newport - 10889981120207

55mm NewPort MIS Cap/Rod Combo
SEASPINE ORTHOPEDICS CORPORATION
60-0255
In Commercial Distribution

  • 10889981120207 ()

  • 55mm
60-0255

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

Newport - 10889981120191

30mm NewPort MIS Cap/Rod Combo
SEASPINE ORTHOPEDICS CORPORATION
60-0230
In Commercial Distribution

  • 10889981120191 ()

  • 30mm
60-0230

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

Malibu - 10889981119829

ESS SUBLAMINAR WIRE, 1 mm
SEASPINE ORTHOPEDICS CORPORATION
15-0010
In Commercial Distribution

  • 10889981119829 ()

  • 1mm
15-0010

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

Malibu - 10889981119652

CLOSED LATERAL CONNECTOR, 5.5/6.35 X 45MM
SEASPINE ORTHOPEDICS CORPORATION
12-0056
In Commercial Distribution

  • 10889981119652 ()

  • 5.5/6.35x45MM
12-0056

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

UCR - 10889981062682

CAP, 5.5/6.75
SEASPINE ORTHOPEDICS CORPORATION
10-0026
In Commercial Distribution

  • 10889981062682 ()

  • 5.5/6.75
10-0026

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