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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DynaBunion RAC Block, Size 0
CROSSROADS EXTREMITY SYSTEMS
DynaBunion RAC Block, Size 0
In Commercial Distribution

  • 00810112598193 ()
280283PKG

  • Orthopaedic instrument surgical connector
DYNABUNION SHORT PLATE TEMPLATE- RT
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION SHORT PLATE TEMPLATE- RT
In Commercial Distribution

  • 00810112598148 ()
TEM270314PKG

  • Surgical implant template, reusable
DYNABUNION SHORT PLATE TEMPLATE- LT
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION SHORT PLATE TEMPLATE- LT
In Commercial Distribution

  • 00810112598131 ()
TEM270312PKG

  • Surgical implant template, reusable
DYNABUNION STANDARD PLATE TEMPLATE- RT
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION STANDARD PLATE TEMPLATE- RT
In Commercial Distribution

  • 00810112598117 ()
TEM270310PKG

  • Surgical implant template, reusable
DYNABUNION STANDARD PLATE TEMPLATE- LT
CROSSROADS EXTREMITY SYSTEMS
DYNABUNION STANDARD PLATE TEMPLATE- LT
In Commercial Distribution

  • 00810112598100 ()
TEM270308PKG

  • Surgical implant template, reusable
DynaBunion Full Custom Non-Sterile Case
CROSSROADS EXTREMITY SYSTEMS
DynaBunion Full Custom Non-Sterile Case
In Commercial Distribution

  • 00810112598094 ()
280600PKG

  • Instrument tray, reusable
MiniBunion Saw Guide
CROSSROADS EXTREMITY SYSTEMS
MiniBunion Saw Guide
In Commercial Distribution

  • 00810112597875 ()
280041PKG

  • Surgical drill guide, reusable
MIS Bunion Plate Inserter
CROSSROADS EXTREMITY SYSTEMS
MIS Bunion Plate Inserter
In Commercial Distribution

  • 00810112597868 ()
280015PKG

  • Orthopaedic inorganic implant inserter/extractor, reusable
MiniBunion Instruments Tray
CROSSROADS EXTREMITY SYSTEMS
MiniBunion Instruments Tray
In Commercial Distribution

  • 00810112597851 ()
280020PKG

  • Instrument tray, reusable
MiniBunion Non-Locking Drill Guide
CROSSROADS EXTREMITY SYSTEMS
MiniBunion Non-Locking Drill Guide
In Commercial Distribution

  • 00810112597844 ()
280012PKG

  • Surgical drill guide, reusable
Ergonomic Toe Separators (Large)
VIVE HEALTH LLC
INS1059BLUL
In Commercial Distribution

  • 10810113575497 ()
  • 00810113575490 ()


  • Toe separator
Ergonomic Toe Separators (Medium)
VIVE HEALTH LLC
INS1059BLUM
In Commercial Distribution

  • 10810113575480 ()
  • 00810113575483 ()


  • Toe separator
Ergonomic Toe Separators (Small)
VIVE HEALTH LLC
INS1059BLUS
In Commercial Distribution

  • 10810113575473 ()
  • 00810113575476 ()


  • Toe separator
Hot and Cold Bunion Sleeves
VIVE HEALTH LLC
RHB3017BLK
In Commercial Distribution

  • 10810113575008 ()
  • 00810113575001 ()


  • Hot/cold therapy pack, reusable
BUNION PODIATRY PACK
MEDLINE INDUSTRIES, INC.
DYNJ88219
In Commercial Distribution

  • 40198459122959 ()
  • 10198459122958 ()
DYNJ88219

  • General surgical procedure kit, non-medicated, 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 - 10° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591446 ()
TG27-510R

  • 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
25° IM - 10° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591439 ()
TG02-510R

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

  • 00810112591415 ()
TG02-010R

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

  • 00810112591309 ()
TG02-005R

  • 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
30° IM - 0° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591231 ()
TG03-000R

  • 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 - 0° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591200 ()
TG22-500R

  • 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
17.5° IM - 0° FP Right - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591187 ()
TG17-500R

  • 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 - 0° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591156 ()
TG01-000R

  • 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 - 0° FP Right- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591132 ()
TG00-500R

  • 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 - 45° FP Left- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591118 ()
TG27-545L

  • 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 - 45° FP Left- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591095 ()
TG22-545L

  • 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 - 45° FP Left- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591040 ()
TG01-045L

  • 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 - 45° FP Left- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591033 ()
TG07-545L

  • 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
30° IM - 40° FP Left- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112591019 ()
TG03-040L

  • 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
25° IM - 40° FP Left- 3D Correction Pin Guide
In Commercial Distribution

  • 00810112590999 ()
TG02-540L

  • Orthopaedic prosthesis implantation positioning instrument, single-use
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