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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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Polyaxial Stab and Grab Driver
Seaspine Orthopedics Corporation
SR-1058
In Commercial Distribution

  • 10889981309169 ()
SR-1058

  • Orthopaedic implant driver
T10 Torque Driver
SUBCHONDRAL SOLUTIONS, INC.
10-4010
In Commercial Distribution

  • 00850017962422 ()
10-4010

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Auxiliary Driver
SAIL FUSION, LLC
90-JFB-301100
In Commercial Distribution

  • 00850053568510 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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
Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit
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, T6 Torx X15TN SS
Accufix Surgical, Inc.
AJDH-T6-X15TN
In Commercial Distribution

  • 00850044114009 ()
AJDH-T6-X15TN

  • Surgical screwdriver, reusable
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