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 Rod, 60 degrees
Seaspine Orthopedics Corporation
50-6260
In Commercial Distribution

  • 10889981043223 ()

  • 60°
50-6260

  • Cannulated surgical drill bit, single-use
Rod, 3.5 x 100mm. 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
50-6195
In Commercial Distribution

  • 10889981043216 ()

  • 3.5 X 100mm
50-6195

  • Cannulated surgical drill bit, single-use
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
Rod, 3.5 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
50-6150
In Commercial Distribution

  • 10889981043162 ()

  • 3.5 X 50mm
50-6150

  • Cannulated surgical drill bit, single-use
Rod, 3.5 x 300mm. 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
50-6090
In Commercial Distribution

  • 10889981043124 ()

  • 3.5 X 300mm
50-6090

  • Cannulated surgical drill bit, single-use
Rod, 3.5 x 70mm. 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
50-6070
Not in Commercial Distribution

  • 10889981043100 ()

  • 3.5 X 70mm
50-6070

  • Cannulated surgical drill bit, single-use
Rod, 3.5 x 60mm. 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
50-6060
In Commercial Distribution

  • 10889981043094 ()

  • 3.5 X 60mm
50-6060

  • Cannulated surgical drill bit, single-use
Rod, 3.5 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
50-6040
Not in Commercial Distribution

  • 10889981043070 ()

  • 3.5 X 40mm
50-6040

  • Cannulated surgical drill bit, single-use
Rod, 3.5 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
50-6030
Not in Commercial Distribution

  • 10889981043063 ()

  • 3.5 X 30mm
50-6030

  • Cannulated surgical drill bit, single-use
Rod, 3.5 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
50-6020
Not in Commercial Distribution

  • 10889981043056 ()

  • 3.5 X 20mm
50-6020

  • Cannulated surgical drill bit, single-use
Occipital Screw, 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
50-5018
Not in Commercial Distribution

  • 10889981043025 ()

  • 18mm
50-5018

  • Cannulated surgical drill bit, single-use
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
Occipital Screw, 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
50-5016
Not in Commercial Distribution

  • 10889981043001 ()

  • 16mm
50-5016

  • Cannulated surgical drill bit, single-use
Occipital Screw, 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
50-5014
In Commercial Distribution

  • 10889981042981 ()

  • 14mm
50-5014

  • Cannulated surgical drill bit, single-use
No Description
Biomet Orthopedics, LLC
31-399999
In Commercial Distribution

  • 00880304309388 ()
31-399999

  • Orthopaedic implant driver
No Description
Biomet Orthopedics, LLC
245015
In Commercial Distribution

  • 00880304288805 ()
245015

  • Surgical screwdriver, reusable
Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2010
Not in Commercial Distribution

  • 10889981049423 ()

  • 10mm
98-2010

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Biomet Orthopedics, LLC
31-108100
In Commercial Distribution

  • 00880304302532 ()
31-108100

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
31-107036
In Commercial Distribution

  • 00880304301993 ()
31-107036

  • Surgical screwdriver, reusable
Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2201
In Commercial Distribution

  • 10889981049577 ()
98-2201

  • Surgical drill guide, reusable
Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2002
In Commercial Distribution

  • 10889981049416 ()
98-2002

  • Surgical drill guide, reusable
Sierra Extended Tab Screw, 04.5 x 50mm
Seaspine Orthopedics Corporation
51-4550
Not in Commercial Distribution

  • 10889981044022 ()

  • 4.5 Dia X 50mm
51-4550

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 40mm
Seaspine Orthopedics Corporation
51-4540
Not in Commercial Distribution

  • 10889981044008 ()

  • 4.5 Dia X 40mm
51-4540

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 38mm
Seaspine Orthopedics Corporation
51-4538
Not in Commercial Distribution

  • 10889981043995 ()

  • 4.5 Dia X 38mm
51-4538

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 34mm
Seaspine Orthopedics Corporation
51-4534
Not in Commercial Distribution

  • 10889981043971 ()

  • 4.5 Dia X 34mm
51-4534

  • Cannulated surgical drill bit, single-use
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 Extended Tab Screw, 04.5 x 28mm
Seaspine Orthopedics Corporation
51-4528
In Commercial Distribution

  • 10889981043940 ()

  • 4.5 Dia X 28mm
51-4528

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 26mm
Seaspine Orthopedics Corporation
51-4526
In Commercial Distribution

  • 10889981043933 ()

  • 4.5 Dia X 26mm
51-4526

  • Cannulated surgical drill bit, single-use
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Extended Tab Screw, 03.5 x 22mm
Seaspine Orthopedics Corporation
51-3522
In Commercial Distribution

  • 10889981043575 ()

  • 3.5 Dia X 22mm
51-3522

  • Cannulated surgical drill bit, single-use
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