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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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The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
12.5° IM - 20° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591606 ()
TG12-520R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
7.5° IM - 20° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591583 ()
TG07-520R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
27.5° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591552 ()
TG27-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
22.5° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591538 ()
TG22-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
20° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591521 ()
TG02-015R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
12.5° IM - 15° FP Right - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591491 ()
TG12-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
CROSSROADS EXTREMITY SYSTEMS
7.5° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591477 ()
TG07-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
PODIATRY BUNION CASE PACK
Cardinal Health 200, LLC
SOP73BPAVA
In Commercial Distribution

  • 50197106990818 ()
  • 10197106990810 ()
SOP73BPAVA

  • Orthopaedic surgical procedure kit, non-medicated, single-use
IR PACK UNION PACK
Cardinal Health 200, LLC
SAN4JIPUN2
In Commercial Distribution

  • 50197106988945 ()
  • 10197106988947 ()
SAN4JIPUN2

  • Cardiothoracic surgical procedure kit, medicated, single-use
BUNION PACK
Cardinal Health 200, LLC
SOP13BUJ11
In Commercial Distribution

  • 50197106961061 ()
  • 10197106961063 ()
SOP13BUJ11

  • Orthopaedic surgical procedure kit, non-medicated, single-use
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