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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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osteo-WEDGE 2.5mm x 10mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-10
In Commercial Distribution

  • M621OW25LBS10MM0 ()

  • 2.5mm x 10mm
OW2.5LBS-10MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 08mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-200-08
In Commercial Distribution

  • M621OW25LBS08MM0 ()

  • 2.5mm x 08mm
OW2.5LBS-08MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE Temporary Tack, 2.4mm x 12mm. Non-sterile single use (disposable) accessory for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-100-12
In Commercial Distribution

  • M621OW24TT12MM0 ()

  • 2.4mm x 12mm
OW2.4TT-12MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-504-30
In Commercial Distribution

  • M621GM504300 ()
GM-504-30

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-504-24
In Commercial Distribution

  • M621GM504240 ()
GM-504-24

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-504-21
In Commercial Distribution

  • M621GM504210 ()
GM-504-21

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-504-18
In Commercial Distribution

  • M621GM504180 ()
GM-504-18

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-504-12
In Commercial Distribution

  • M621GM504120 ()
GM-504-12

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-504-09
In Commercial Distribution

  • M621GM504090 ()
GM-504-09

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-504-06
In Commercial Distribution

  • M621GM504060 ()
GM-504-06

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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