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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-WEDGE2 Opening Wedge Bone Locking System -Kit (containing non-sterile single use implants (2.5mm locking bone screws, 3.0mm locking bone screws and bone plates), non-sterile single use temporary tacks and non-sterile reusable instruments). 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
CarryingCase2
In Commercial Distribution

  • M621CARRYINGCASE20 ()
CarryingCase2

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE2 Drill Guide, a reusable instrument, 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-160-04
In Commercial Distribution

  • M621GM160040 ()
GM-160-04

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE2 Drill Guide, a reusable instrument, 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-160-03
In Commercial Distribution

  • M621GM160030 ()
GM-160-03

  • 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-503-06
In Commercial Distribution

  • M621GM503060 ()
GM-503-06

  • 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-503-30
In Commercial Distribution

  • M621GM503300 ()
GM-503-30

  • 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-504-30
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-503-03
In Commercial Distribution

  • M621GM503030 ()
GM-503-03

  • 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-504-03
In Commercial Distribution

  • M621GM504030 ()
GM-504-03

  • 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-503-27
In Commercial Distribution

  • M621GM503270 ()
GM-503-27

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