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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INTREPED 09 Driver
Auxano Medical LLC
01-40209
In Commercial Distribution

  • 00850055649163 ()
01-40209

  • Orthopaedic bone screw (non-sliding)
INTREPED 06 Driver
Auxano Medical LLC
01-40206
In Commercial Distribution

  • 00850055649156 ()
01-40206

  • Orthopaedic bone screw (non-sliding)
Auxiliary Driver
SAIL FUSION, LLC
90-JFB-301100
In Commercial Distribution

  • 00850053568510 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Threaded Driver
DUNAMIS MEDICAL, LLC
1001610
In Commercial Distribution

  • 00850052601157 ()
1001610

  • Orthopaedic fixation suture button
Fixed Adapter with Driver Array
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682478 ()
IN0211301

  • Orthopaedic stereotactic surgery system
Rotating Adapter with Driver Array
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682195 ()
IN0211701

  • Orthopaedic stereotactic surgery system
Hex Driver
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682119 ()
IN0210801

  • Orthopaedic stereotactic surgery system
HOLO SL Reduction Driver Lock Tube
Surgalign Spine Technologies, Inc.
154000150
In Commercial Distribution

  • 00850028694701 ()


  • Surgical screwdriver, reusable
HOLO Streamline Driver, Lock Tube
Surgalign Spine Technologies, Inc.
154000140
In Commercial Distribution

  • 00850028694688 ()


  • Surgical screwdriver, reusable
HOLO Streamline Driver, Open Cannulated
Surgalign Spine Technologies, Inc.
154000131
In Commercial Distribution

  • 00850028694671 ()


  • Surgical screwdriver, reusable
HOLO Streamline Driver, Solid
Surgalign Spine Technologies, Inc.
154000130
In Commercial Distribution

  • 00850028694664 ()


  • Surgical screwdriver, reusable
HOLO Hex Driver, Sterile
Surgalign Spine Technologies, Inc.
154000056
In Commercial Distribution

  • 00850028694121 ()


  • Multi-purpose stereotactic surgery system
Streamline MIS Driver, Nav
Surgalign Spine Technologies, Inc.
154000028
In Commercial Distribution

  • 00850028694114 ()


  • Surgical screwdriver, reusable
MIS Driver
Fusion Robotics, LLC
1061
In Commercial Distribution

  • 00850026574500 ()
1061

  • Surgical screwdriver, reusable
8mm Hex Driver, Reference Arm
Fusion Robotics, LLC
1066
In Commercial Distribution

  • 00850026574258 ()


  • Surgical screwdriver, reusable
Driver
Fusion Robotics, LLC
1060
In Commercial Distribution

  • 00850026574234 ()


  • Surgical screwdriver, reusable
Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit
Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide
DRIVER 6550006 5.5/6.0 SV SET SCREW DRVR
MEDTRONIC SOFAMOR DANEK, INC.
6550006
In Commercial Distribution

  • 00643169754539 ()


  • Surgical screwdriver, reusable
DRIVER NAV6550005 5.5/6.0 SV NAV MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV6550005
In Commercial Distribution

  • 00643169754522 ()


  • Surgical screwdriver, reusable
DRIVER 6550004 BALL-ENDED DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550004
In Commercial Distribution

  • 00643169754515 ()


  • Surgical screwdriver, reusable
DRIVER 6550003 5.5/6.0 SV NON-RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
6550003
In Commercial Distribution

  • 00643169754508 ()


  • Surgical screwdriver, reusable
DRIVER 6550002 5.5/6.0 SV MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550002
In Commercial Distribution

  • 00643169754492 ()


  • Surgical screwdriver, reusable
DRIVER EX0316044 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0316044
In Commercial Distribution

  • 00643169747678 ()


  • Orthopaedic implant driver
DRIVER EX0216058 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0216058
In Commercial Distribution

  • 00643169746831 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER EX0216057 THREADED ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0216057
In Commercial Distribution

  • 00643169746824 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER X0116073 PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
X0116073
In Commercial Distribution

  • 00643169731530 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX0116074 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0116074
In Commercial Distribution

  • 00643169731462 ()


  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER NAV3606195 NAVIGATD THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV3606195
In Commercial Distribution

  • 00643169725461 ()


  • Surgical screwdriver, reusable
DRIVER EX0116014 T25 RETAINING TWIST
MEDTRONIC SOFAMOR DANEK, INC.
EX0116014
In Commercial Distribution

  • 00643169723351 ()


  • Surgical screwdriver, reusable
SLEEVE EX1015066 SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1015066
In Commercial Distribution

  • 00643169722200 ()


  • Orthopaedic implantation sleeve, reusable
STARTER 5580135 SETSCREW T27
MEDTRONIC SOFAMOR DANEK, INC.
5580135
In Commercial Distribution

  • 00643169714731 ()


  • Surgical screwdriver, reusable
Screw, 5mm, Burr Hole Cover
ST. JUDE MEDICAL, INC.
6015
In Commercial Distribution

  • 15414734403075 ()
  • 05414734403078 ()
6015

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Cranial Burr Hole Cover Sys.
ST. JUDE MEDICAL, INC.
6010
In Commercial Distribution

  • 05414734403061 ()
6010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
DRIVER EX0416035 5.5/6.0 FAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0416035
In Commercial Distribution

  • 00643169764194 ()


  • Surgical screwdriver, reusable
DRIVER EX0514021 TAPERED HEX 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0514021
In Commercial Distribution

  • 00643169523562 ()


  • Orthopaedic implant driver
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