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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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LONESTAR - 18257200115518

7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 6
Orthofix US LLC
84-7306
In Commercial Distribution

  • 18257200115518 ()


  • Metallic spinal interbody fusion cage

LONESTAR - 18257200115501

0° IMPLANT, SERRATED RADIAL RIBS, 15 X 15 X 14
Orthofix US LLC
84-5614
In Commercial Distribution

  • 18257200115501 ()


  • Metallic spinal interbody fusion cage

LONESTAR - 18257200115495

0° IMPLANT, SERRATED RADIAL RIBS, 15 X 15 X 13
Orthofix US LLC
84-5613
In Commercial Distribution

  • 18257200115495 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200110629

SKYHAWK - INTERBODY INSTRUMENT TRAY KIT
Orthofix US LLC
450427-0003
In Commercial Distribution

  • 18257200110629 ()
27-9091

  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200108916

DRIVER
Orthofix US LLC
24-1094
In Commercial Distribution

  • 18257200108916 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200108909

FINAL TIGHTENING DRIVER
Orthofix US LLC
24-1092
In Commercial Distribution

  • 18257200108909 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200108893

5.5MM DRILL
Orthofix US LLC
24-1065
In Commercial Distribution

  • 18257200108893 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200108886

AWL
Orthofix US LLC
24-1062
In Commercial Distribution

  • 18257200108886 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200108879

AWL SLEEVE
Orthofix US LLC
24-1061
In Commercial Distribution

  • 18257200108879 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200108862

RONGEUR, BONE BITING
Orthofix US LLC
24-1050
In Commercial Distribution

  • 18257200108862 ()


  • Metallic spinal interbody fusion cage
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