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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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Sierra™ - 10889981042356

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

Sierra™ - 10889981042349

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

Sierra™ - 10889981042325

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

N/A - 00681490917025

ACC 963-850 FIGHTER INSERT/REMOVAL TOOL
MEDTRONIC NAVIGATION, INC.
963-850
In Commercial Distribution

  • 00681490917025 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00681490912310

INSTRUMENT 80615525 QC SCREW REMOVER
MEDTRONIC SOFAMOR DANEK, INC.
80615525
In Commercial Distribution

  • 00681490912310 ()


  • Surgical screwdriver, reusable

na - 00681490909563

INSTR 8361023 3D 7 32 STSCR SCKT DR 3D
MEDTRONIC SOFAMOR DANEK, INC.
8361023
In Commercial Distribution

  • 00681490909563 ()


  • Orthopaedic implant driver

N/A - 00681490907149

INSTRUMENT 8951808 18MM DRIVER SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
8951808
In Commercial Distribution

  • 00681490907149 ()


  • Orthopaedic implantation sleeve, reusable

Medtronic Reusable Instruments - 00681490906753

T-HANDLE W/ MINI HUDSON QC
MEDTRONIC SOFAMOR DANEK, INC.
X0101012
In Commercial Distribution

  • 00681490906753 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00681490904810

INSTRUMENT 8950003 TAPRD IMP DRVR WRENCH
MEDTRONIC SOFAMOR DANEK, INC.
8950003
In Commercial Distribution

  • 00681490904810 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00681490904803

INSTRUMENT 8950001 DBL DISTRCTR DRVR CAP
MEDTRONIC SOFAMOR DANEK, INC.
8950001
In Commercial Distribution

  • 00681490904803 ()


  • Orthopaedic implant driver
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