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

  • 10889881192120 ()
95-6204

  • Orthopaedic surgical distractor, internal
ALIF Modular Spreader Inserter, T-Handle
SEASPINE ORTHOPEDICS CORPORATION
95-6203
Not in Commercial Distribution

  • 10889881192113 ()
95-6203

  • Orthopaedic surgical distractor, internal
S2S CrossBar, 33 - 47mm. 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
50-2023
Not in Commercial Distribution

  • 10889910059165 ()

  • 33 - 47mm
50-2023

  • Vertebral body prosthesis, non-sterile
S2S CrossBar, 27 - 35mm. 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
50-2022
Not in Commercial Distribution

  • 10889910059158 ()

  • 27 - 35mm
50-2022

  • Vertebral body prosthesis, non-sterile
S2S CrossBar, 24 - 29mm. 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
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile
Sierra 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
50-1005
Not in Commercial Distribution

  • 10889910059134 ()
50-1005

  • Vertebral body prosthesis, non-sterile
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
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
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
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
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
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
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
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
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
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
30mm Trial, 0 Deg, 11 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-3011
In Commercial Distribution

  • 10889981048631 ()

  • 30mm , 0°, 11 mm
14-20-3011

  • Orthopaedic implant inserter/extractor, reusable
30mm Trial, 0 Deg, 10 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-3010
In Commercial Distribution

  • 10889981048624 ()

  • 30mm , 0°, 10 mm
14-20-3010

  • Orthopaedic implant inserter/extractor, reusable
30mm Trial, 0 Deg, 9 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-3009
In Commercial Distribution

  • 10889981048617 ()

  • 30mm , 0°, 9 mm
14-20-3009

  • Orthopaedic implant inserter/extractor, reusable
30mm Trial, 0 Deg, 8 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-3008
In Commercial Distribution

  • 10889981048600 ()

  • 30mm , 0°, 8 mm
14-20-3008

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 16 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2616
In Commercial Distribution

  • 10889981048594 ()

  • 26mm , 0°, 16 mm
14-20-2616

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 15 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2615
In Commercial Distribution

  • 10889981048587 ()

  • 26mm , 0°, 15 mm
14-20-2615

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 14 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2614
In Commercial Distribution

  • 10889981048570 ()

  • 26mm , 0°, 14 mm
14-20-2614

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 13 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2613
In Commercial Distribution

  • 10889981048563 ()

  • 26mm , 0°, 13 mm
14-20-2613

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 12 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2612
In Commercial Distribution

  • 10889981048556 ()

  • 26mm , 0°, 12 mm
14-20-2612

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 11 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2611
In Commercial Distribution

  • 10889981048549 ()

  • 26mm , 0°, 11 mm
14-20-2611

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 10 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2610
In Commercial Distribution

  • 10889981048532 ()

  • 26mm , 0°, 10 mm
14-20-2610

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 9 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2609
In Commercial Distribution

  • 10889981048525 ()

  • 26mm , 0°, 9 mm
14-20-2609

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 0 Deg, 8 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2608
In Commercial Distribution

  • 10889981048518 ()

  • 26mm , 0°, 8 mm
14-20-2608

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 16 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2216
In Commercial Distribution

  • 10889981048501 ()

  • 22mm , 0°, 16 mm
14-20-2216

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 15 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2215
In Commercial Distribution

  • 10889981048495 ()

  • 22mm , 0°, 15 mm
14-20-2215

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 14 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2214
In Commercial Distribution

  • 10889981048488 ()

  • 22mm , 0°, 14 mm
14-20-2214

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 13 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2213
In Commercial Distribution

  • 10889981048471 ()

  • 22mm , 0°, 13 mm
14-20-2213

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 12 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2212
In Commercial Distribution

  • 10889981048464 ()

  • 22mm , 0°, 12 mm
14-20-2212

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 11 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2211
In Commercial Distribution

  • 10889981048457 ()

  • 22mm , 0°, 11 mm
14-20-2211

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 10 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2210
In Commercial Distribution

  • 10889981048440 ()

  • 22mm , 0°, 10 mm
14-20-2210

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 9 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2209
In Commercial Distribution

  • 10889981048433 ()

  • 22mm , 0°, 9 mm
14-20-2209

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 0 Deg, 8 mm
SEASPINE ORTHOPEDICS CORPORATION
14-20-2208
In Commercial Distribution

  • 10889981048426 ()

  • 22mm , 0°, 8 mm
14-20-2208

  • Orthopaedic implant inserter/extractor, reusable
22mm Starter Trial
SEASPINE ORTHOPEDICS CORPORATION
14-20-2206
In Commercial Distribution

  • 10889981048419 ()

  • 22mm
14-20-2206

  • Orthopaedic implant inserter/extractor, reusable
Thoraco-Lumbar Set Screw (BFSS-952-B)
SEASPINE ORTHOPEDICS CORPORATION
20-12-0001
In Commercial Distribution

  • 10889981048402 ()
20-12-0001

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 60mm Bone Screw (BFS-700-60-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0060
In Commercial Distribution

  • 10889981048396 ()

  • 60mm
20-11-0060

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 55mm Bone Screw (BFS-700-55-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0055
In Commercial Distribution

  • 10889981048389 ()

  • 55mm
20-11-0055

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 50mm Bone Screw (BFS-700-50-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0050
In Commercial Distribution

  • 10889981048372 ()

  • 50mm
20-11-0050

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 45mm Bone Screw (BFS-700-45-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0045
In Commercial Distribution

  • 10889981048365 ()

  • 45mm
20-11-0045

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 40mm Bone Screw (BFS-700-40-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0040
In Commercial Distribution

  • 10889981048358 ()

  • 40mm
20-11-0040

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 35mm Bone Screw (BFS-700-35-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0035
In Commercial Distribution

  • 10889981048341 ()

  • 35mm
20-11-0035

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 30mm Bone Screw (BFS-700-30-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0030
In Commercial Distribution

  • 10889981048334 ()

  • 30mm
20-11-0030

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 25mm Bone Screw (BFS-700-25-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0025
In Commercial Distribution

  • 10889981048327 ()

  • 25mm
20-11-0025

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 20mm Bone Screw (BFS-700-20-B)
SEASPINE ORTHOPEDICS CORPORATION
20-11-0020
In Commercial Distribution

  • 10889981048310 ()

  • 20mm
20-11-0020

  • Spinal fixation plate, non-bioabsorbable
Thoraco-Lumbar 117mm Plate (BFP-75-10-C)
SEASPINE ORTHOPEDICS CORPORATION
20-10-0117-10
In Commercial Distribution

  • 10889981048303 ()

  • 117mm
20-10-0117-10

  • Spinal fixation plate, non-bioabsorbable
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