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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
20° IM - 0° FP Left - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112590098 ()
TG02-000L

  • 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 Left - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112590081 ()
TG17-500L

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

  • 00810112590074 ()
TG01-500L

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

  • 00810112590067 ()
TG12-500L

  • 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 Left - 3D Correction Pin Guide
In Commercial Distribution

  • 00810112590050 ()
TG01-000L

  • Orthopaedic prosthesis implantation positioning instrument, single-use
Bunion Correction Implants
Treace Medical Concepts, Inc.
SK57
In Commercial Distribution

  • 00810111222464 ()


  • Orthopaedic fixation plate, non-bioabsorbable
  • Orthopaedic bone screw (non-sliding)
Pack Superficial Venous F/ Venous Institute of Buffalo
HENRY SCHEIN, INC.
5703505
In Commercial Distribution

  • 00304040178812 ()
  • 10304040178819 ()
5703505

  • General surgical procedure kit, non-medicated, single-use
No Description
STRYKER CORPORATION
2760-300-000
Not in Commercial Distribution

  • 57613327261276 ()
  • 07613327261271 ()
2760-300-000

  • Foot friction/impact protector
No Description
STRYKER CORPORATION
2760-200-000
Not in Commercial Distribution

  • 57613327261252 ()
  • 07613327261257 ()
2760-200-000

  • Foot friction/impact protector
BHS DEMO UNIT Biomet EBI Bone Healing System Demonstration Unit Not For Human Use
EBI, LLC
1068339
In Commercial Distribution

  • 00812301020676 ()
1068339

  • Patient-worn bone growth electromagnetic stimulator
International Wall Plug Adapter Kit
EBI, LLC
1068317
In Commercial Distribution

  • 00812301020669 ()
1068317

  • Patient-worn bone growth electromagnetic stimulator
WALL AC ADAPTER
EBI, LLC
1068315
In Commercial Distribution

  • 00812301020652 ()
1068315

  • Patient-worn bone growth electromagnetic stimulator
STRAP, SFLX CLAVICLE COILETE
EBI, LLC
1068314
In Commercial Distribution

  • 00812301020645 ()
1068314

  • Patient-worn bone growth electromagnetic stimulator
STRAP, SFLX STANDARD COILETTE
EBI, LLC
1068313
In Commercial Distribution

  • 00812301020638 ()
1068313

  • Patient-worn bone growth electromagnetic stimulator
SFLX - XL COILETTE
EBI, LLC
1068240
In Commercial Distribution

  • 00812301020621 ()
1068240

  • Patient-worn bone growth electromagnetic stimulator
SFLX - MINI COILETTE
EBI, LLC
1068239
In Commercial Distribution

  • 00812301020614 ()
1068239

  • Patient-worn bone growth electromagnetic stimulator
SFLX - COILETTE
EBI, LLC
1068238
In Commercial Distribution

  • 00812301020607 ()
1068238

  • Patient-worn bone growth electromagnetic stimulator
SFLX 4-4 COIL
EBI, LLC
1068237
In Commercial Distribution

  • 00812301020591 ()
1068237

  • Patient-worn bone growth electromagnetic stimulator
SFLX 4-1 COIL
EBI, LLC
1068236
In Commercial Distribution

  • 00812301020584 ()
1068236

  • Patient-worn bone growth electromagnetic stimulator
SFLX 4 COIL
EBI, LLC
1068235
In Commercial Distribution

  • 00812301020577 ()
1068235

  • Patient-worn bone growth electromagnetic stimulator
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