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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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Slap Hammer (tuning fork style)
CAPTIVA SPINE, INC.
CSE06-R-1000-29
In Commercial Distribution

  • 00850065741239 ()


  • Surgical mallet
Hammer power shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-26
In Commercial Distribution

  • 00850065741055 ()


  • Surgical mallet
Hammer connecting shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-28
In Commercial Distribution

  • 00850065741048 ()


  • Surgical mallet
Square Cage Driver
CAPTIVA SPINE, INC.
CSE06-R-0500-48
In Commercial Distribution

  • 00850065741031 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006892 ()
1456-6565

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headless Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006878 ()
1456-1408

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006854 ()
1456-3030

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Orthopaedic intraoperative positioning pin, single-use
3.5MM HEX U-JOINT DRIVER
Conformis, Inc.
1080-561
In Commercial Distribution

  • 00850268007552 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER, RIGID, 3.5MM HEX
Conformis, Inc.
1080-560
In Commercial Distribution

  • 00850268007545 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300035
In Commercial Distribution

  • 00850073363294 ()


  • Surgical screwdriver, reusable
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