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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

Malibu - 10889981003753

Monoaxial Screw, 6.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
16-6545
In Commercial Distribution

  • 10889981003753 ()

  • 6.5 x 45mm
16-6545

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

Malibu - 10889981003739

Monoaxial Screw, 6.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
16-6535
In Commercial Distribution

  • 10889981003739 ()

  • 6.5 x 35mm
16-6535

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

Malibu - 10889981003715

MONOAXIAL SCREW, 5.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
16-5555
Not in Commercial Distribution

  • 10889981003715 ()

  • 5.5 x 55mm
16-5555

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

Malibu - 10889981003609

MONOAXIAL SCREW, 4.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
16-4520
Not in Commercial Distribution

  • 10889981003609 ()

  • 4.5 x 20mm
16-4520

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

Malibu - 10889981003593

Malibu Set Screw
SEASPINE ORTHOPEDICS CORPORATION
16-0015
In Commercial Distribution

  • 10889981003593 ()
16-0015

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

Malibu - 10889981003579

MALIBU DLTA SCREW 7.5 DIA X 80 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7580
Not in Commercial Distribution

  • 10889981003579 ()

  • 7.5 DIA X 80 mm
15-7580

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

Malibu - 10889981003470

MALIBU DLTA SCREW 7.5 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7530
Not in Commercial Distribution

  • 10889981003470 ()

  • 7.5 DIA X 30 mm
15-7530

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

Malibu - 10889981003456

MALIBU DLTA SCREW 7.0 DIA X 65 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7065
Not in Commercial Distribution

  • 10889981003456 ()

  • 7.0 DIA X 65 mm
15-7065

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

Malibu - 10889981003258

MALIBU DLTA SCREW 6.0 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6040
Not in Commercial Distribution

  • 10889981003258 ()

  • 6.0 DIA X 40 mm
15-6040

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

Malibu - 10889981003210

MALIBU DLTA SCREW 5.5 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5555
Not in Commercial Distribution

  • 10889981003210 ()

  • 5.5 DIA X 55 mm
15-5555

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

Malibu - 10889981003197

MALIBU DLTA SCREW 5.5 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5545
In Commercial Distribution

  • 10889981003197 ()

  • 5.5 DIA X 45 mm
15-5545

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

Malibu - 10889981003159

MALIBU DLTA SCREW 5.5 DIA X 25 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5525
In Commercial Distribution

  • 10889981003159 ()

  • 5.5 DIA X 25 mm
15-5525

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

Malibu - 10889981003135

MALIBU DLTA SCREW 5.0 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5045
Not in Commercial Distribution

  • 10889981003135 ()

  • 5.0 DIA X 45 mm
15-5045

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

Malibu - 10889981003128

MALIBU DLTA SCREW 5.0 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5040
In Commercial Distribution

  • 10889981003128 ()

  • 5.0 DIA X 40 mm
15-5040

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

Malibu - 10889981003111

MALIBU DLTA SCREW 5.0 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5035
In Commercial Distribution

  • 10889981003111 ()

  • 5.0 DIA X 35 mm
15-5035

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

Malibu - 10889981003067

MALIBU DLTA SCREW 4.5 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4535
In Commercial Distribution

  • 10889981003067 ()

  • 4.5 DIA X 35 mm
15-4535

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

Malibu - 10889981003050

MALIBU DLTA SCREW 4.5 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4530
In Commercial Distribution

  • 10889981003050 ()

  • 4.5 DIA X 30 mm
15-4530

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

Malibu - 10889981003043

MALIBU DLTA SCREW 4.5 DIA X 25 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4525
In Commercial Distribution

  • 10889981003043 ()

  • 4.5 DIA X 25 mm
15-4525

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

Malibu - 10889981003036

MALIBU DLTA SCREW 4.5 DIA X 20 mm
SEASPINE ORTHOPEDICS CORPORATION
15-4520
Not in Commercial Distribution

  • 10889981003036 ()

  • 4.5 DIA X 20 mm
15-4520

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

UCR - 10889981003029

Cap, LP
SEASPINE ORTHOPEDICS CORPORATION
14-0020
In Commercial Distribution

  • 10889981003029 ()

  • LP
14-0020

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

UCR - 10889981003012

SetScrew, LP
SEASPINE ORTHOPEDICS CORPORATION
14-0010
In Commercial Distribution

  • 10889981003012 ()

  • LP
14-0010

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

Malibu - 10889981003005

Malibu Polyaxial Reduction Screw,8.5 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
13-8595
Not in Commercial Distribution

  • 10889981003005 ()

  • 8.5 x 95mm
13-8595

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

Malibu - 10889981002992

Malibu Polyaxial Reduction Screw,8.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
13-8590
In Commercial Distribution

  • 10889981002992 ()

  • 8.5 x 90mm
13-8590

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

Malibu - 10889981002985

Malibu Polyaxial Reduction Screw,8.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
13-8585
Not in Commercial Distribution

  • 10889981002985 ()

  • 8.5 x 85mm
13-8585

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

Malibu - 10889981002978

Malibu Polyaxial Reduction Screw,8.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
13-8580
In Commercial Distribution

  • 10889981002978 ()

  • 8.5 x 80mm
13-8580

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

Malibu - 10889981002961

Malibu Polyaxial Reduction Screw,8.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
13-8575
Not in Commercial Distribution

  • 10889981002961 ()

  • 8.5 x 75mm
13-8575

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

Malibu - 10889981002954

Malibu Polyaxial Reduction Screw,8.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
13-8570
Not in Commercial Distribution

  • 10889981002954 ()

  • 8.5 x 70mm
13-8570

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

Malibu - 10889981002947

Malibu Polyaxial Reduction Screw,8.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
13-8565
Not in Commercial Distribution

  • 10889981002947 ()

  • 8.5 x 65mm
13-8565

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

Malibu - 10889981002930

Malibu Polyaxial Reduction Screw,8.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
13-8560
Not in Commercial Distribution

  • 10889981002930 ()

  • 8.5 x 60mm
13-8560

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

Malibu - 10889981002916

Malibu Polyaxial Reduction Screw,8.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
13-8550
Not in Commercial Distribution

  • 10889981002916 ()

  • 8.5 x 50mm
13-8550

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

Malibu - 10889981002909

Malibu Polyaxial Reduction Screw,8.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
13-8545
Not in Commercial Distribution

  • 10889981002909 ()

  • 8.5 x 45mm
13-8545

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

Malibu - 10889981002893

Malibu Polyaxial Reduction Screw,8.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
13-8540
Not in Commercial Distribution

  • 10889981002893 ()

  • 8.5 x 40mm
13-8540

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

Malibu - 10889981002886

Malibu Polyaxial Reduction Screw,8.5 x 35m
SEASPINE ORTHOPEDICS CORPORATION
13-8535
Not in Commercial Distribution

  • 10889981002886 ()

  • 8.5 x 35m
13-8535

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

Malibu - 10889981002879

Malibu Polyaxial Reduction Screw,8.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-8530
Not in Commercial Distribution

  • 10889981002879 ()

  • 8.5 x 30mm
13-8530

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

Malibu - 10889981002862

Malibu Polyaxial Reduction Screw,8.5 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
13-8510
In Commercial Distribution

  • 10889981002862 ()

  • 8.5 x 110mm
13-8510

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

Malibu - 10889981002855

Malibu Polyaxial Reduction Screw,8.5 x 105mm
SEASPINE ORTHOPEDICS CORPORATION
13-8505
Not in Commercial Distribution

  • 10889981002855 ()

  • 8.5 x 105mm
13-8505

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

Malibu - 10889981002824

Malibu Polyaxial Reduction Screw,8.0 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
13-8090
Not in Commercial Distribution

  • 10889981002824 ()

  • 8.0 x 90mm
13-8090

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

Malibu - 10889981002817

Malibu Polyaxial Reduction Screw,8.0 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
13-8085
Not in Commercial Distribution

  • 10889981002817 ()

  • 8.0 x 85mm
13-8085

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

Malibu - 10889981002701

Malibu Polyaxial Reduction Screw,8.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
13-8030
Not in Commercial Distribution

  • 10889981002701 ()

  • 8.0 x 30mm
13-8030

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

Malibu - 10889981002695

Malibu Polyaxial Reduction Screw,8.0 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
13-8010
Not in Commercial Distribution

  • 10889981002695 ()

  • 8.0 x 110mm
13-8010

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

Malibu - 10889981002688

Malibu Polyaxial Reduction Screw,8.0 x 105mm
SEASPINE ORTHOPEDICS CORPORATION
13-8005
Not in Commercial Distribution

  • 10889981002688 ()

  • 8.0 x 105mm
13-8005

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

Malibu - 10889981002657

Malibu Polyaxial Reduction Screw,7.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
13-7590
Not in Commercial Distribution

  • 10889981002657 ()

  • 7.5 x 90mm
13-7590

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

Malibu - 10889981002640

Malibu Polyaxial Reduction Screw,7.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
13-7585
Not in Commercial Distribution

  • 10889981002640 ()

  • 7.5 x 85mm
13-7585

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

Malibu - 10889981002626

Malibu Polyaxial Reduction Screw,7.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
13-7575
Not in Commercial Distribution

  • 10889981002626 ()

  • 7.5 x 75mm
13-7575

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

Malibu - 10889981002602

Malibu Polyaxial Reduction Screw,7.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
13-7565
In Commercial Distribution

  • 10889981002602 ()

  • 7.5 x 65mm
13-7565

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