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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

Sierra™ - 10889981043964

Sierra Extended Tab Screw, 04.5 x 32mm
SEASPINE ORTHOPEDICS CORPORATION
51-4532
Not in Commercial Distribution

  • 10889981043964 ()

  • 4.5 Dia X 32mm
51-4532

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043957

Sierra Extended Tab Screw, 04.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
51-4530
Not in Commercial Distribution

  • 10889981043957 ()

  • 4.5 Dia X 30mm
51-4530

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043926

Sierra Extended Tab Screw, 04.5 x 24mm
SEASPINE ORTHOPEDICS CORPORATION
51-4524
In Commercial Distribution

  • 10889981043926 ()

  • 4.5 Dia X 24mm
51-4524

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043919

Sierra Extended Tab Screw, 04.5 x 22mm
SEASPINE ORTHOPEDICS CORPORATION
51-4522
In Commercial Distribution

  • 10889981043919 ()

  • 4.5 Dia X 22mm
51-4522

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043902

Sierra Extended Tab Screw, 04.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
51-4520
In Commercial Distribution

  • 10889981043902 ()

  • 4.5 Dia X 20mm
51-4520

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043896

Sierra Extended Tab Screw, 04.5 x 18mm
SEASPINE ORTHOPEDICS CORPORATION
51-4518
In Commercial Distribution

  • 10889981043896 ()

  • 4.5 Dia X 18mm
51-4518

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043889

Sierra Extended Tab Screw, 04.5 x 16mm
SEASPINE ORTHOPEDICS CORPORATION
51-4516
In Commercial Distribution

  • 10889981043889 ()

  • 4.5 Dia X 16mm
51-4516

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043872

Sierra Extended Tab Screw, 04.5 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
51-4514
In Commercial Distribution

  • 10889981043872 ()

  • 4.5 Dia X 14mm
51-4514

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043865

Sierra Extended Tab Screw, 04.5 x 12mm
SEASPINE ORTHOPEDICS CORPORATION
51-4512
In Commercial Distribution

  • 10889981043865 ()

  • 4.5 Dia X 12mm
51-4512

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043858

Sierra Extended Tab Screw, 04.5 x 10mm
SEASPINE ORTHOPEDICS CORPORATION
51-4510
Not in Commercial Distribution

  • 10889981043858 ()

  • 4.5 Dia X 10mm
51-4510

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043841

Sierra Extended Tab Screw, 04.5 x 8mm
SEASPINE ORTHOPEDICS CORPORATION
51-4508
Not in Commercial Distribution

  • 10889981043841 ()

  • 4.5 Dia X 8mm
51-4508

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043834

Sierra Extended Tab Screw, 04.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
51-4040
Not in Commercial Distribution

  • 10889981043834 ()

  • 4.0 Dia X 40mm
51-4040

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043827

Sierra Extended Tab Screw, 04.0 x 38mm
SEASPINE ORTHOPEDICS CORPORATION
51-4038
Not in Commercial Distribution

  • 10889981043827 ()

  • 4.0 Dia X 38mm
51-4038

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043810

Sierra Extended Tab Screw, 04.0 x 36mm
SEASPINE ORTHOPEDICS CORPORATION
51-4036
Not in Commercial Distribution

  • 10889981043810 ()

  • 4.0 Dia X 36mm
51-4036

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043803

Sierra Extended Tab Screw, 04.0 x 34mm
SEASPINE ORTHOPEDICS CORPORATION
51-4034
Not in Commercial Distribution

  • 10889981043803 ()

  • 4.0 Dia X 34mm
51-4034

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043797

Sierra Extended Tab Screw, 04.0 x 32mm
SEASPINE ORTHOPEDICS CORPORATION
51-4032
Not in Commercial Distribution

  • 10889981043797 ()

  • 4.0 Dia X 32mm
51-4032

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043780

Sierra Extended Tab Screw, 04.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
51-4030
In Commercial Distribution

  • 10889981043780 ()

  • 4.0 Dia X 30mm
51-4030

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043773

Sierra Extended Tab Screw, 04.0 x 28mm
SEASPINE ORTHOPEDICS CORPORATION
51-4028
In Commercial Distribution

  • 10889981043773 ()

  • 4.0 Dia X 28mm
51-4028

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043766

Sierra Extended Tab Screw, 04.0 x 26mm
SEASPINE ORTHOPEDICS CORPORATION
51-4026
In Commercial Distribution

  • 10889981043766 ()

  • 4.0 Dia X 26mm
51-4026

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043759

Sierra Extended Tab Screw, 04.0 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
51-4024
In Commercial Distribution

  • 10889981043759 ()

  • 4.0 Dia X 24mm
51-4024

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043742

Sierra Extended Tab Screw, 04.0 x 22mm
SEASPINE ORTHOPEDICS CORPORATION
51-4022
In Commercial Distribution

  • 10889981043742 ()

  • 4.0 Dia X 22mm
51-4022

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043735

Sierra Extended Tab Screw, 04.0 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
51-4020
In Commercial Distribution

  • 10889981043735 ()

  • 4.0 Dia X 20mm
51-4020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043728

Sierra Extended Tab Screw, 04.0 x 18mm
SEASPINE ORTHOPEDICS CORPORATION
51-4018
In Commercial Distribution

  • 10889981043728 ()

  • 4.0 Dia X 18mm
51-4018

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043711

Sierra Extended Tab Screw, 04.0 x 16mm
SEASPINE ORTHOPEDICS CORPORATION
51-4016
In Commercial Distribution

  • 10889981043711 ()

  • 4.0 Dia X 16mm
51-4016

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043704

Sierra Extended Tab Screw, 04.0 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
51-4014
In Commercial Distribution

  • 10889981043704 ()

  • 4.0 Dia X 14mm
51-4014

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043698

Sierra Extended Tab Screw, 04.0 x 12mm
SEASPINE ORTHOPEDICS CORPORATION
51-4012
In Commercial Distribution

  • 10889981043698 ()

  • 4.0 Dia X 12mm
51-4012

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043681

Sierra Extended Tab Screw, 04.0 x 10mm
SEASPINE ORTHOPEDICS CORPORATION
51-4010
In Commercial Distribution

  • 10889981043681 ()

  • 4.0 Dia X 10mm
51-4010

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043674

Sierra Extended Tab Screw, 04.0 x 8mm
SEASPINE ORTHOPEDICS CORPORATION
51-4008
Not in Commercial Distribution

  • 10889981043674 ()

  • 4.0 Dia X 8mm
51-4008

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043667

Sierra Extended Tab Screw, 03.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
51-3540
Not in Commercial Distribution

  • 10889981043667 ()

  • 3.5 Dia X 40mm
51-3540

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043650

Sierra Extended Tab Screw, 03.5 x 38mm
SEASPINE ORTHOPEDICS CORPORATION
51-3538
Not in Commercial Distribution

  • 10889981043650 ()

  • 3.5 Dia X 38mm
51-3538

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043643

Sierra Extended Tab Screw, 03.5 x 36mm
SEASPINE ORTHOPEDICS CORPORATION
51-3536
Not in Commercial Distribution

  • 10889981043643 ()

  • 3.5 Dia X 36mm
51-3536

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043636

Sierra Extended Tab Screw, 03.5 x 34mm
SEASPINE ORTHOPEDICS CORPORATION
51-3534
Not in Commercial Distribution

  • 10889981043636 ()

  • 3.5 Dia X 34mm
51-3534

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043629

Sierra Extended Tab Screw, 03.5 x 32mm
SEASPINE ORTHOPEDICS CORPORATION
51-3532
Not in Commercial Distribution

  • 10889981043629 ()

  • 3.5 Dia X 32mm
51-3532

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043612

Sierra Extended Tab Screw, 03.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
51-3530
In Commercial Distribution

  • 10889981043612 ()

  • 3.5 Dia X 30mm
51-3530

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043605

Sierra Extended Tab Screw, 03.5 x 28mm
SEASPINE ORTHOPEDICS CORPORATION
51-3528
In Commercial Distribution

  • 10889981043605 ()

  • 3.5 Dia X 28mm
51-3528

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043599

Sierra Extended Tab Screw, 03.5 x 26mm
SEASPINE ORTHOPEDICS CORPORATION
51-3526
In Commercial Distribution

  • 10889981043599 ()

  • 3.5 Dia X 26mm
51-3526

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043582

Sierra Extended Tab Screw, 03.5 x 24mm
SEASPINE ORTHOPEDICS CORPORATION
51-3524
In Commercial Distribution

  • 10889981043582 ()

  • 3.5 Dia X 24mm
51-3524

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043568

Sierra Extended Tab Screw, 03.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
51-3520
In Commercial Distribution

  • 10889981043568 ()

  • 3.5 Dia X 20mm
51-3520

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043551

Sierra Extended Tab Screw, 03.5 x 18mm
SEASPINE ORTHOPEDICS CORPORATION
51-3518
In Commercial Distribution

  • 10889981043551 ()

  • 3.5 Dia X 18mm
51-3518

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043544

Sierra Extended Tab Screw, 03.5 x 16mm
SEASPINE ORTHOPEDICS CORPORATION
51-3516
In Commercial Distribution

  • 10889981043544 ()

  • 3.5 Dia X 16mm
51-3516

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043520

Sierra Extended Tab Screw, 03.5 x 12mm
SEASPINE ORTHOPEDICS CORPORATION
51-3512
In Commercial Distribution

  • 10889981043520 ()

  • 3.5 Dia X 12mm
51-3512

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043223

Occipital Rod, 60 degrees
SEASPINE ORTHOPEDICS CORPORATION
50-6260
In Commercial Distribution

  • 10889981043223 ()

  • 60°
50-6260

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043209

Rod, 3.5 x 90mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-6190
In Commercial Distribution

  • 10889981043209 ()

  • 3.5 X 90mm
50-6190

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043193

Rod, 3.5 x 80mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-6180
In Commercial Distribution

  • 10889981043193 ()

  • 3.5 X 80mm
50-6180

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043018

Occipital Screw, 17mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-5017
Not in Commercial Distribution

  • 10889981043018 ()

  • 17mm
50-5017

  • Cannulated surgical drill bit, single-use
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