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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 Bone Plate 08mm - M621GM501080

osteo-WEDGE Bone Plate 08mm. 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-501-08
In Commercial Distribution

  • M621GM501080 ()

  • 08mm
GM-501-08

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

osteo-WEDGE Bone Plate 06mm - M621GM501060

osteo-WEDGE Bone Plate 06mm. 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-501-06
In Commercial Distribution

  • M621GM501060 ()

  • 06mm
GM-501-06

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

osteo-WEDGE Bone Plate 04mm - M621GM501040

osteo-WEDGE Bone Plate 04mm. 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-501-04
In Commercial Distribution

  • M621GM501040 ()

  • 04mm
GM-501-04

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

osteo-WEDGE Bone Plate 02mm - M621GM501020

osteo-WEDGE Bone Plate 02mm. 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-501-02
In Commercial Distribution

  • M621GM501020 ()

  • 02mm
GM-501-02

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

osteo-WEDGE Bone Plate 00mm - M621GM501000

osteo-WEDGE Bone Plate 00mm. 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-501-00
In Commercial Distribution

  • M621GM501000 ()

  • 0mm
GM-501-00

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

osteo-WEDGE2 Drill Guide - M621GM160040

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 - M621GM160030

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

osteo-WEDGE Drill Guide - M621GM160010

osteo-WEDGE 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-160-01
In Commercial Distribution

  • M621GM160010 ()

  • Length: 1.65 Inches (41.91mm)
GM-160-01

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

osteo-WEDGE Screw Retainer Sleeve - M621GM150040

osteo-WEDGE Screw Retainer Sleeve, 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-150-04
In Commercial Distribution

  • M621GM150040 ()

  • Length: 2.68 Inches (68.0mm)
GM-150-04

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

osteo-WEDGE Driver - M621GM150030

osteo-WEDGE Driver, 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-150-03
In Commercial Distribution

  • M621GM150030 ()

  • Length: 6.89 Inches (175.0mm)
GM-150-03

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