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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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Contoured Crossbar, Large, 3.5 Rod. 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
50-2013
In Commercial Distribution

  • 10889981042356 ()

  • 3.5
50-2013

  • Cannulated surgical drill bit, single-use
Contoured Crossbar, Medium, 3.5 Rod. 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
50-2012
In Commercial Distribution

  • 10889981042349 ()

  • 3.5
50-2012

  • Cannulated surgical drill bit, single-use
Contoured Crossbar, Small, 3.5 Rod. 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
50-2011
In Commercial Distribution

  • 10889981042332 ()

  • 3.5
50-2011

  • Cannulated surgical drill bit, single-use
Sierra Locking Cap. 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
50-1000
In Commercial Distribution

  • 10889981042325 ()
50-1000

  • Cannulated surgical drill bit, single-use
Closed Lateral Connector, 3.5 Rod. 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
50-0035
In Commercial Distribution

  • 10889981042318 ()

  • 3.5
50-0035

  • Cannulated surgical drill bit, single-use
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543494 ()
GCLPFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543487 ()
GCLRFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543470 ()
GCLPBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543456 ()
FFCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
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