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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-WEDGE 3.0mm x 26mm Locking Bone Screw - M621OW30LBS26MM0

osteo-WEDGE 3.0mm x 26mm 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-500-26
In Commercial Distribution

  • M621OW30LBS26MM0 ()

  • 3.0mm x 26mm
OW3.0LBS-26MM

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

osteo-WEDGE 3.0mm x 24mm Locking Bone Screw - M621OW30LBS24MM0

osteo-WEDGE 3.0mm x 24mm 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-500-24
In Commercial Distribution

  • M621OW30LBS24MM0 ()

  • 3.0mm x 24mm
OW3.0LBS-24MM

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

osteo-WEDGE 3.0mm x 22mm Locking Bone Screw - M621OW30LBS22MM0

osteo-WEDGE 3.0mm x 22mm 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-500-22
In Commercial Distribution

  • M621OW30LBS22MM0 ()

  • 3.0mm x 22mm
OW3.0LBS-22MM

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

osteo-WEDGE 3.0mm x 20mm Locking Bone Screw - M621OW30LBS20MM0

osteo-WEDGE 3.0mm x 20mm Locking Bone Screw. 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-500-20
In Commercial Distribution

  • M621OW30LBS20MM0 ()

  • 3.0mm x 20mm
OW3.0LBS-20MM

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

osteo-WEDGE 3.0mm x 18mm Locking Bone Screw - M621OW30LBS18MM0

osteo-WEDGE 3.0mm x 18mm 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-500-18
In Commercial Distribution

  • M621OW30LBS18MM0 ()

  • 3.0mm x 18mm
OW3.0LBS-18MM

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