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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 Device Size Type Device Class Implantable

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Anterior Disc Prep - 10889881192120

ALIF Modular Spreader Inserter, Inner Shaft
SEASPINE ORTHOPEDICS CORPORATION
95-6204
Not in Commercial Distribution

  • 10889881192120 ()
95-6204

  • Orthopaedic surgical distractor, internal

Anterior Disc Prep - 10889881192113

ALIF Modular Spreader Inserter, T-Handle
SEASPINE ORTHOPEDICS CORPORATION
95-6203
Not in Commercial Distribution

  • 10889881192113 ()
95-6203

  • Orthopaedic surgical distractor, internal

Sierra™ - 10889910059127

Axial Rod Connector, 3.5/6.35. 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
50-0935
Not in Commercial Distribution

  • 10889910059127 ()

  • 3.5/6.35
50-0935

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059110

Axial Rod Connector, 3.5/5.5. 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
50-0835
Not in Commercial Distribution

  • 10889910059110 ()

  • 3.5/5.5
50-0835

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059103

Axial Rod Connector, 3.5/3.5. 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
50-0735
Not in Commercial Distribution

  • 10889910059103 ()

  • 3.5/3.5
50-0735

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059097

Parallel Rod Connector, 3.5/6.35, Single. 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
50-0635
Not in Commercial Distribution

  • 10889910059097 ()

  • 3.5/6.35
50-0635

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059080

Parallel Rod Connector, 3.5/5.5, Single. 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
50-0535
Not in Commercial Distribution

  • 10889910059080 ()

  • 3.5/5.5
50-0535

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059073

Parallel Rod Connector, 3.5/3.5, Single. 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
50-0435
Not in Commercial Distribution

  • 10889910059073 ()

  • 3.5/3.5
50-0435

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059066

Parallel Rod Connector, 3.5/6.35, Double. 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
50-0335
Not in Commercial Distribution

  • 10889910059066 ()

  • 3.5/6.35
50-0335

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059059

Parallel Rod Connector, 3.5/5.5, Double. 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
50-0235
Not in Commercial Distribution

  • 10889910059059 ()

  • 3.5/5.5
50-0235

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059042

Parallel Rod Connector, 3.5/3.5, Double. 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
50-0135
Not in Commercial Distribution

  • 10889910059042 ()

  • 3.5/3.5
50-0135

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059035

Connector Set Screw. 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
50-0015
Not in Commercial Distribution

  • 10889910059035 ()
50-0015

  • Vertebral body prosthesis, 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 - 10889981062668

SETSCREW, 5.5/6.75
SEASPINE ORTHOPEDICS CORPORATION
10-0016
In Commercial Distribution

  • 10889981062668 ()

  • 5.5/6.75mm
10-0016

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

Pacifica™ - 10889981062644

Pacifica Hybrid Implant
SEASPINE ORTHOPEDICS CORPORATION
PACHIMP
In Commercial Distribution

  • 10889981062644 ()
PACHIMP

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062620

Laminoplasty Implant Set
SEASPINE ORTHOPEDICS CORPORATION
LAMNIM
In Commercial Distribution

  • 10889981062620 ()
LAMNIM

  • Vertebral body prosthesis, non-sterile

Hollywood™ NanoMetalene® - 10889981062613

Hollywood Nanometalene Implants
SEASPINE ORTHOPEDICS CORPORATION
HOLNMIMP
In Commercial Distribution

  • 10889981062613 ()
HOLNMIMP

  • Vertebral body prosthesis, non-sterile

Hollywood™ - 10889981062606

Hollywood VI Implant
SEASPINE ORTHOPEDICS CORPORATION
HOLVIIMP
In Commercial Distribution

  • 10889981062606 ()
HOLVIIMP

  • Vertebral body prosthesis, non-sterile

Hollywood™ - 10889981062590

Hollywood VI 30mm Implant Caddy Implants
SEASPINE ORTHOPEDICS CORPORATION
HOLVI30IMP
In Commercial Distribution

  • 10889981062590 ()

  • 30mm
HOLVI30IMP

  • Vertebral body prosthesis, non-sterile

Hollywood™ - 10889981062583

Hollywood Implant
SEASPINE ORTHOPEDICS CORPORATION
HOLIMP
In Commercial Distribution

  • 10889981062583 ()
HOLIMP

  • Vertebral body prosthesis, non-sterile

Zuma™ - 10889981062576

Zuma-LP Caddy Implant
SEASPINE ORTHOPEDICS CORPORATION
ZUMLPIMP
In Commercial Distribution

  • 10889981062576 ()
ZUMLPIMP

  • Instrument tray, reusable

Zuma™ - 10889981062552

Zuma 38mm, 8 Deg Implants
SEASPINE ORTHOPEDICS CORPORATION
ZUM388IMP
In Commercial Distribution

  • 10889981062552 ()

  • 38mm, 8 Deg
ZUM388IMP

  • Instrument tray, reusable

Vu aPod™ - L - 10889981062415

Vu aPod-L Narrow Implant
SEASPINE ORTHOPEDICS CORPORATION
VAPODLNIMP
In Commercial Distribution

  • 10889981062415 ()
VAPODLNIMP

  • Instrument tray, reusable

Vu aPod™ - L - 10889981062408

Vu-aPOD-L 60mm Wide Optional Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
VAPODL60WIMP
In Commercial Distribution

  • 10889981062408 ()

  • 60mm
VAPODL60WIMP

  • Instrument tray, reusable

Vu aPod™ - L - 10889981062385

Vu-aPOD-L 45mm Wide Optional Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
VAPODL45WIMP
In Commercial Distribution

  • 10889981062385 ()

  • 45mm
VAPODL45WIMP

  • Instrument tray, reusable

Vu aPod™ - L - 10889981062361

Vu-aPOD-L 40mm Narrow Optional Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
VAPODL40NIMP
In Commercial Distribution

  • 10889981062361 ()

  • 40mm
VAPODL40NIMP

  • Instrument tray, reusable

Vu aPod™ - L - 10889981062347

Vu-aPOD-L 50 mm-55 mm Wide w-SpinPlate Implant Cad
SEASPINE ORTHOPEDICS CORPORATION
VAPDL50SPIMP
In Commercial Distribution

  • 10889981062347 ()

  • 50 mm-55 mm
VAPDL50SPIMP

  • Instrument tray, reusable

Vu a-POD™ - 10889981062330

Vu aPOD Prime Anterior IBF Implants
SEASPINE ORTHOPEDICS CORPORATION
VUAPOD2IMP
In Commercial Distribution

  • 10889981062330 ()
VUAPOD2IMP

  • Instrument tray, reusable

Sonoma™ - 10889981062316

Sonoma Implant
SEASPINE ORTHOPEDICS CORPORATION
SONIMP
In Commercial Distribution

  • 10889981062316 ()
SONIMP

  • Instrument tray, reusable

Sierra™ - 10889981062309

Sierra Extended Tab Screw Caddy
SEASPINE ORTHOPEDICS CORPORATION
SEXTIMP
In Commercial Distribution

  • 10889981062309 ()
SEXTIMP

  • Instrument tray, reusable

Sierra™ - 10889981062293

Sierra Occipital Plate Implant
SEASPINE ORTHOPEDICS CORPORATION
SEROIMP
In Commercial Distribution

  • 10889981062293 ()
SEROIMP

  • Instrument tray, reusable

Sierra™ - 10889981062286

Sierra Implant
SEASPINE ORTHOPEDICS CORPORATION
SERAIMP
In Commercial Distribution

  • 10889981062286 ()
SERAIMP

  • Instrument tray, reusable

Coral - 10889981062248

Coral Friction Instruments 2
SEASPINE ORTHOPEDICS CORPORATION
CORF2RDIMP
In Commercial Distribution

  • 10889981062248 ()
CORF2RDIMP

  • Instrument tray, reusable

Cambria™ - 10889981062224

Cambria Implant
SEASPINE ORTHOPEDICS CORPORATION
CAMIMP
In Commercial Distribution

  • 10889981062224 ()
CAMIMP

  • Instrument tray, reusable

Cambria™ - 10889981062217

Cambria Flat Implant
SEASPINE ORTHOPEDICS CORPORATION
CAMFIMP
In Commercial Distribution

  • 10889981062217 ()
CAMFIMP

  • Instrument tray, reusable

BodyForm™ - 10889981062194

BodyForm Thoraco-Lumbar Fixation System
SEASPINE ORTHOPEDICS CORPORATION
BODYFRMIMP
In Commercial Distribution

  • 10889981062194 ()
BODYFRMIMP

  • Instrument tray, reusable

Laminoplasty - 10889981062170

Lamina Sizing Trial, 6mm
SEASPINE ORTHOPEDICS CORPORATION
95-2406
In Commercial Distribution

  • 10889981062170 ()

  • 6mm L
95-2406

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062156

Plate Sizing Trial, 16mm L
SEASPINE ORTHOPEDICS CORPORATION
95-2316
In Commercial Distribution

  • 10889981062156 ()

  • 16mm L
95-2316

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062132

Plate Sizing Trial, 12mm L
SEASPINE ORTHOPEDICS CORPORATION
95-2312
In Commercial Distribution

  • 10889981062132 ()

  • 12mm L
95-2312

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981061975

Self Drilling Lamina Screw, Ø2.7mm x 7mm L
SEASPINE ORTHOPEDICS CORPORATION
52-2707
In Commercial Distribution

  • 10889981061975 ()

  • 2.7mm Dia x 7mm L
52-2707

  • Vertebral body prosthesis, non-sterile
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