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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
17.5° IM - 15° FP Right - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591514 ()
TG17-515R

  • 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
15° IM - 15° FP Right - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591507 ()
TG01-515R

  • 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
10° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591484 ()
TG01-015R

  • 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
5° IM - 15° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591460 ()
TG00-515R

  • Orthopaedic prosthesis implantation positioning instrument, single-use
Fluidized Heel Boot
Mölnlycke Health Care AB
1400123
In Commercial Distribution

  • 07323190249558 ()
  • 07323190250554 ()

  • One size


  • Foot friction/impact protector
Fluidized Heel Boot
Mölnlycke Health Care AB
1400122
In Commercial Distribution

  • 07323190249510 ()
  • 07323190250547 ()

  • One size


  • Foot friction/impact protector
NEUROLOGY INSTITUTE PACK
Cardinal Health 200, LLC
SNE29NEAKD
In Commercial Distribution

  • 50195594380579 ()
  • 10195594380571 ()
SNE29NEAKD

  • Neurosurgical procedure kit, non-medicated, single-use
BUNION PACK
Cardinal Health 200, LLC
SOP13BUJB2
In Commercial Distribution

  • 50195594378118 ()
  • 10195594378110 ()
SOP13BUJB2

  • Orthopaedic surgical procedure kit, non-medicated, single-use
NEUROLOGY INSTITUTE PACK
Cardinal Health 200, LLC
SNE29NEAK6
In Commercial Distribution

  • 50195594391988 ()
  • 10195594391980 ()
SNE29NEAK6

  • Neurosurgical procedure kit, non-medicated, single-use
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVMYJ
In Commercial Distribution

  • 50195594341013 ()
  • 10195594341015 ()
SCV31HVMYJ

  • Cardiothoracic surgical procedure kit, medicated, single-use
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