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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Occipital Screw, 11mm. 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
50-5011
In Commercial Distribution

  • 10889981042950 ()

  • 11mm
50-5011

  • Cannulated surgical drill bit, single-use
Occipital Screw, 10mm. 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
50-5010
In Commercial Distribution

  • 10889981042943 ()

  • 10mm
50-5010

  • Cannulated surgical drill bit, single-use
Occipital Screw, 9mm. 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
50-5009
In Commercial Distribution

  • 10889981042936 ()

  • 9mm
50-5009

  • Cannulated surgical drill bit, single-use
Occipital Screw, 8mm. 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
50-5008
In Commercial Distribution

  • 10889981042929 ()

  • 8mm
50-5008

  • Cannulated surgical drill bit, single-use
Occipital Screw, 7mm. 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
50-5007
In Commercial Distribution

  • 10889981042912 ()

  • 7mm
50-5007

  • Cannulated surgical drill bit, single-use
Occipital Screw, 6mm. 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
50-5006
In Commercial Distribution

  • 10889981042905 ()

  • 6mm
50-5006

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 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
50-4550
Not in Commercial Distribution

  • 10889981042899 ()

  • 4.5 Dia X 50mm
50-4550

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 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
50-4545
Not in Commercial Distribution

  • 10889981042882 ()

  • 4.5 Dia X 45mm
50-4545

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 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
50-4540
Not in Commercial Distribution

  • 10889981042875 ()

  • 4.5 Dia X 40mm
50-4540

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 38mm. 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
50-4538
Not in Commercial Distribution

  • 10889981042868 ()

  • 4.5 Dia X 38mm
50-4538

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 36mm. 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
50-4536
Not in Commercial Distribution

  • 10889981042851 ()

  • 4.5 Dia X 36mm
50-4536

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 34mm. 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
50-4534
Not in Commercial Distribution

  • 10889981042844 ()

  • 4.5 Dia X 34mm
50-4534

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 32mm. 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
50-4532
In Commercial Distribution

  • 10889981042837 ()

  • 4.5 Dia X 32mm
50-4532

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 30mm. 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
50-4530
Not in Commercial Distribution

  • 10889981042820 ()

  • 4.5 Dia X 30mm
50-4530

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 28mm. 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
50-4528
In Commercial Distribution

  • 10889981042813 ()

  • 4.5 Dia X 28mm
50-4528

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 26mm. 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
50-4526
Not in Commercial Distribution

  • 10889981042806 ()

  • 4.5 Dia X 26mm
50-4526

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 24mm. 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
50-4524
In Commercial Distribution

  • 10889981042790 ()

  • 4.5 Dia X 24mm
50-4524

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 22mm. 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
50-4522
Not in Commercial Distribution

  • 10889981042783 ()

  • 4.5 Dia X 22mm
50-4522

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 20mm. 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
50-4520
In Commercial Distribution

  • 10889981042776 ()

  • 4.5 Dia X 20mm
50-4520

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 18mm. 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
50-4518
Not in Commercial Distribution

  • 10889981042769 ()

  • 4.5 Dia X 18mm
50-4518

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 16mm. 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
50-4516
Not in Commercial Distribution

  • 10889981042752 ()

  • 4.5 Dia X 16mm
50-4516

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 14mm. 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
50-4514
Not in Commercial Distribution

  • 10889981042745 ()

  • 4.5 Dia X 14mm
50-4514

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 12mm. 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
50-4512
Not in Commercial Distribution

  • 10889981042738 ()

  • 4.5 Dia X 12mm
50-4512

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 10mm. 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
50-4510
In Commercial Distribution

  • 10889981042721 ()

  • 4.5 Dia X 10mm
50-4510

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 8mm. 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
50-4508
Not in Commercial Distribution

  • 10889981042714 ()

  • 4.5 Dia X 8mm
50-4508

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 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
50-4040
Not in Commercial Distribution

  • 10889981042707 ()

  • 4.0 Dia X 40mm
50-4040

  • Cannulated surgical drill bit, single-use
Solid Screw 9.00 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
41-9040-1
In Commercial Distribution

  • 10889981069643 ()

  • 9.00 x 40mm
41-9040-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 9.00 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
41-9030-1
In Commercial Distribution

  • 10889981069629 ()

  • 9.00 x 30mm
41-9030-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 9.00 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
41-9025-1
In Commercial Distribution

  • 10889981069612 ()

  • 9.00 x 25mm
41-9025-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 9.00 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
41-9011-1
In Commercial Distribution

  • 10889981069599 ()

  • 9.00 x 110mm
41-9011-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.50 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
41-8545-1
In Commercial Distribution

  • 10889981069476 ()

  • 8.50 x 45mm
41-8545-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.50 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
41-8535-1
In Commercial Distribution

  • 10889981069452 ()

  • 8.50 x 35mm
41-8535-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.50 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
41-8530-1
In Commercial Distribution

  • 10889981069445 ()

  • 8.50 x 30mm
41-8530-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.50 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
41-8525-1
In Commercial Distribution

  • 10889981069438 ()

  • 8.50 x 25mm
41-8525-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.50 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
41-8511-1
In Commercial Distribution

  • 10889981069414 ()

  • 8.50 x 110mm
41-8511-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.50 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
41-8510-1
In Commercial Distribution

  • 10889981069407 ()

  • 8.50 x 100mm
41-8510-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.00 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
41-8085-1
In Commercial Distribution

  • 10889981069377 ()

  • 8.00 x 85mm
41-8085-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.00 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
41-8025-1
In Commercial Distribution

  • 10889981069254 ()

  • 8.00 x 25mm
41-8025-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 8.00 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
41-8011-1
In Commercial Distribution

  • 10889981069230 ()

  • 8.00 x 110mm
41-8011-1

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Screw 8.00 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
41-8010-2
In Commercial Distribution

  • 10889981069223 ()

  • 8.00 x 100mm
41-8010-2

  • Bone-screw internal spinal fixation system, non-sterile
Extended Trauma Seat
SEASPINE ORTHOPEDICS CORPORATION
41-8000
In Commercial Distribution

  • 10889981069193 ()
41-8000

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 7.50 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
41-7565-1
In Commercial Distribution

  • 10889981069056 ()

  • 7.50 x 65mm
41-7565-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 7.50 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
41-7560-1
In Commercial Distribution

  • 10889981069032 ()

  • 7.50 x 60mm
41-7560-1

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Screw 7.50 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
41-7550-2
In Commercial Distribution

  • 10889981069001 ()

  • 7.50 x 50mm
41-7550-2

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Screw 7.50 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
41-7545-2
In Commercial Distribution

  • 10889981068981 ()

  • 7.50 x 45mm
41-7545-2

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 7.50 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
41-7545-1
In Commercial Distribution

  • 10889981068974 ()

  • 7.50 x 45mm
41-7545-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 7.50 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
41-7540-1
In Commercial Distribution

  • 10889981068950 ()

  • 7.50 x 40mm
41-7540-1

  • Bone-screw internal spinal fixation system, non-sterile
Solid Screw 7.00 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
41-7085-1
In Commercial Distribution

  • 10889981068776 ()

  • 7.00 x 85mm
41-7085-1

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Screw 7.00 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
41-7075-2
In Commercial Distribution

  • 10889981068745 ()

  • 7.00 x 75mm
41-7075-2

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Screw 7.00 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
41-7070-2
In Commercial Distribution

  • 10889981068721 ()

  • 7.00 x 70mm
41-7070-2

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