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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Cambria Rasp, 17 x 13 x 7mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9917
In Commercial Distribution

  • 10889981094102 ()

  • 17 x 13 x 7mm
93-9917

  • Bone file/rasp, manual, reusable
Cambria Rasp, 17 x 13 x 6mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9916
In Commercial Distribution

  • 10889981094096 ()

  • 17 x 13 x 6mm
93-9916

  • Bone file/rasp, manual, reusable
Cambria Rasp, 17 x 13 x 5mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9915
In Commercial Distribution

  • 10889981094089 ()

  • 17 x 13 x 5mm
93-9915

  • Bone file/rasp, manual, reusable
Cambria NM Trial w/ Depth Stop, Flat 17x13, 12mm
SEASPINE ORTHOPEDICS CORPORATION
93-9862
In Commercial Distribution

  • 10889981094072 ()

  • 17x13, 12mm
93-9862

  • Spinal implant trial
Cambria NM Trial w/ Depth Stop, Flat 17x13, 11mm
SEASPINE ORTHOPEDICS CORPORATION
93-9861
In Commercial Distribution

  • 10889981094065 ()

  • 17x13, 11mm
93-9861

  • Spinal implant trial
Thoracic 62mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0062
In Commercial Distribution

  • 10889981057718 ()

  • 62mm
19-10-0062

  • Spinal fixation plate, non-bioabsorbable
Thoracic 60mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0060
In Commercial Distribution

  • 10889981057701 ()

  • 60mm
19-10-0060

  • Spinal fixation plate, non-bioabsorbable
Thoracic 44mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0044
Not in Commercial Distribution

  • 10889981057695 ()

  • 44mm
19-10-0044

  • Spinal fixation plate, non-bioabsorbable
Thoracic 43mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0043
Not in Commercial Distribution

  • 10889981057688 ()

  • 43mm
19-10-0043

  • Spinal fixation plate, non-bioabsorbable
Thoracic 42mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0042
Not in Commercial Distribution

  • 10889981057671 ()

  • 42mm
19-10-0042

  • Spinal fixation plate, non-bioabsorbable
Thoracic 41mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0041
Not in Commercial Distribution

  • 10889981057664 ()

  • 41mm
19-10-0041

  • Spinal fixation plate, non-bioabsorbable
Thoracic 40mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0040
Not in Commercial Distribution

  • 10889981057657 ()

  • 40mm
19-10-0040

  • Spinal fixation plate, non-bioabsorbable
Occipital Plate, 45-55mm. 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
50-8024
In Commercial Distribution

  • 10889981057640 ()

  • 45-55mm
50-8024

  • Vertebral body prosthesis, non-sterile
Occipital Plate, 40-50mm. 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
50-8023
In Commercial Distribution

  • 10889981057633 ()

  • 40-50mm
50-8023

  • Vertebral body prosthesis, non-sterile
Occipital Plate, 35-45mm. 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
50-8022
In Commercial Distribution

  • 10889981057626 ()

  • 35-45mm
50-8022

  • Vertebral body prosthesis, non-sterile
Occipital Plate, 30-40mm. 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
50-8021
In Commercial Distribution

  • 10889981057619 ()

  • 30-40mm
50-8021

  • Vertebral body prosthesis, non-sterile
Occipital Plate, 25-35mm. 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
50-8020
In Commercial Distribution

  • 10889981057602 ()

  • 25-35mm
50-8020

  • Vertebral body prosthesis, non-sterile
Screw - Self-Tapping - Variable - 4.5x17mm
SEASPINE ORTHOPEDICS CORPORATION
22-24-4517
In Commercial Distribution

  • 10889981057589 ()

  • 4.5x17mm
22-24-4517

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.5x15mm
SEASPINE ORTHOPEDICS CORPORATION
22-24-4515
In Commercial Distribution

  • 10889981057572 ()

  • 4.5x15mm
22-24-4515

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.5x13mm
SEASPINE ORTHOPEDICS CORPORATION
22-24-4513
In Commercial Distribution

  • 10889981057565 ()

  • 4.5x13mm
22-24-4513

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x18 mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4018
In Commercial Distribution

  • 10889981057558 ()

  • 4.0x18 mm
22-23-4018

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x17 mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4017
Not in Commercial Distribution

  • 10889981057541 ()

  • 4.0x17 mm
22-23-4017

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x16mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4016
In Commercial Distribution

  • 10889981057534 ()

  • 4.0x16mm
22-23-4016

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x15 mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4015
Not in Commercial Distribution

  • 10889981057527 ()

  • 4.0x15 mm
22-23-4015

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x14mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4014
In Commercial Distribution

  • 10889981057510 ()

  • 4.0x14mm
22-23-4014

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x13 mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4013
In Commercial Distribution

  • 10889981057503 ()

  • 4.0x13 mm
22-23-4013

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x12 mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4012
In Commercial Distribution

  • 10889981057497 ()

  • 4.0x12 mm
22-23-4012

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x11 mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4011
Not in Commercial Distribution

  • 10889981057480 ()

  • 4.0x11 mm
22-23-4011

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Tapping - Variable - 4.0x10mm
SEASPINE ORTHOPEDICS CORPORATION
22-23-4010
In Commercial Distribution

  • 10889981057473 ()

  • 4.0x10mm
22-23-4010

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.5x19mm
SEASPINE ORTHOPEDICS CORPORATION
22-22-4519
In Commercial Distribution

  • 10889981057466 ()

  • 4.5x19mm
22-22-4519

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.5x17mm
SEASPINE ORTHOPEDICS CORPORATION
22-22-4517
In Commercial Distribution

  • 10889981057459 ()

  • 4.5x17mm
22-22-4517

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.5x15mm
SEASPINE ORTHOPEDICS CORPORATION
22-22-4515
In Commercial Distribution

  • 10889981057442 ()

  • 4.5x15mm
22-22-4515

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.5x13mm
SEASPINE ORTHOPEDICS CORPORATION
22-22-4513
In Commercial Distribution

  • 10889981057435 ()

  • 4.5x13mm
22-22-4513

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.5x11mm
SEASPINE ORTHOPEDICS CORPORATION
22-22-4511
In Commercial Distribution

  • 10889981057428 ()

  • 4.5x11mm
22-22-4511

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.0x18mm
SEASPINE ORTHOPEDICS CORPORATION
22-21-4018
In Commercial Distribution

  • 10889981057411 ()

  • 4.0x18mm
22-21-4018

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.0x17mm
SEASPINE ORTHOPEDICS CORPORATION
22-21-4017
In Commercial Distribution

  • 10889981057404 ()

  • 4.0x17mm
22-21-4017

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.0x16mm
SEASPINE ORTHOPEDICS CORPORATION
22-21-4016
In Commercial Distribution

  • 10889981057398 ()

  • 4.0x16mm
22-21-4016

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.0x15mm
SEASPINE ORTHOPEDICS CORPORATION
22-21-4015
In Commercial Distribution

  • 10889981057381 ()

  • 4.0x15mm
22-21-4015

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.0x14mm
SEASPINE ORTHOPEDICS CORPORATION
22-21-4014
In Commercial Distribution

  • 10889981057374 ()

  • 4.0x14mm
22-21-4014

  • Spinal fixation plate, non-bioabsorbable
Screw - Self-Drilling - Variable - 4.0x13mm
SEASPINE ORTHOPEDICS CORPORATION
22-21-4013
In Commercial Distribution

  • 10889981057367 ()

  • 4.0x13mm
22-21-4013

  • Spinal fixation plate, non-bioabsorbable
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