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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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Golden Isles Pedicle Screw System - G079C5090000080

Decorticator
Intelivation, LLC
C50-9000-008
In Commercial Distribution

  • G079C5090000080 ()


  • Bone-resection orthopaedic reamer, reusable

Golden Isles Pedicle Screw System - G079C5090000070

Head Reamer
Intelivation, LLC
C50-9000-007
In Commercial Distribution

  • G079C5090000070 ()


  • Bone-resection orthopaedic reamer, reusable

Golden Isles Pedicle Screw System - G079C5090000030

Palm Handle, Standard
Intelivation, LLC
C50-9000-003
In Commercial Distribution

  • G079C5090000030 ()


  • Surgical instrument handle, non-torque-limiting

Golden Isles Pedicle Screw System - G079C5090000020

Axial Handle, Dynamo
Intelivation, LLC
C50-9000-002
In Commercial Distribution

  • G079C5090000020 ()


  • Surgical instrument handle, non-torque-limiting

Golden Isles Pedicle Screw System - G079C5090000010

Cleaning Stylet
Intelivation, LLC
C50-9000-001
In Commercial Distribution

  • G079C5090000010 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

MIS Golden Isles Pedicle Screw System - G079C5080000210

Impaction Cap
Intelivation, LLC
C50-8000-021
In Commercial Distribution

  • G079C5080000210 ()


  • Orthopaedic implant impactor, reusable

MIS Golden Isles Pedicle Screw System - G079C5080000200

Shorter Driver
Intelivation, LLC
C50-8000-020
In Commercial Distribution

  • G079C5080000200 ()


  • Surgical screwdriver, reusable

MIS Golden Isles Pedicle Screw System - G079C5080000160

Set Screw Shaft C/D
Intelivation, LLC
C50-8000-016
In Commercial Distribution

  • G079C5080000160 ()


  • Surgical screwdriver, reusable

MIS Golden Isles Pedicle Screw System - G079C5080000110

MIS Rod Holder
Intelivation, LLC
C50-8000-011
In Commercial Distribution

  • G079C5080000110 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

MIS Golden Isles Pedicle Screw System - G079C5080000090

Screw Depth Measuring Instrument
Intelivation, LLC
C50-8000-009
In Commercial Distribution

  • G079C5080000090 ()


  • Surgical depth gauge, reusable
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