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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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MIS Screw Driver Advance Tool, Cannulated
SPINAL RESOURCES, INC.
2-112
In Commercial Distribution

  • B51521120 ()


  • General internal orthopaedic fixation system implantation kit
MIS Polyscrew Driver, Cannulated
SPINAL RESOURCES, INC.
2-111
In Commercial Distribution

  • B51521110 ()


  • General internal orthopaedic fixation system implantation kit
FN AR Driver Bolt
Flow-FX
101-54
In Commercial Distribution

  • B267101540 ()
101-54

  • Orthopaedic bone bolt
FN Cap Driver Bolt
Flow-FX
101-41
In Commercial Distribution

  • B267101410 ()
101-41

  • Orthopaedic bone bolt
FN Lag Screw Driver Bolt
Flow-FX
101-27
In Commercial Distribution

  • B267101270 ()
101-27

  • Orthopaedic bone bolt
LOCKING DRIVER, WHT PEARL
Osseus Fusion Systems, LLC
2100-6100
In Commercial Distribution

  • B06221006100 ()
2100-6100

  • Metallic spinal interbody fusion cage
K-wire 45mm screw Standard Driver
Intelivation, LLC
C50-8000-022
In Commercial Distribution

  • G079C5080000220 ()


  • Orthopaedic bone pin, non-bioabsorbable
Single-Use Instrumentation Kit, T15
DIAMOND ORTHOPEDIC, LLC
DMD-KIT-150T15-S
In Commercial Distribution

  • B551DMDKIT150T15S0 ()
DMD-KIT-150T15-S

  • Orthopaedic bone pin, non-bioabsorbable
  • Cannulated surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
Single-Use Instrumentation Kit, T10
DIAMOND ORTHOPEDIC, LLC
DMD-KIT-150T10-S
In Commercial Distribution

  • B551DMDKIT150T10S0 ()
DMD-KIT-150T10-S

  • Orthopaedic bone pin, non-bioabsorbable
  • Cannulated surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
Single-Use Instrumentation Kit, T05
DIAMOND ORTHOPEDIC, LLC
DMD-KIT-125T05-S
In Commercial Distribution

  • B551DMDKIT125T05S0 ()
DMD-KIT-125T05-S

  • Orthopaedic bone pin, non-bioabsorbable
  • Cannulated surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
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