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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 20mm 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-200-20
In Commercial Distribution

  • M621OW25LBS20MM0 ()

  • 2.5mm x 20mm
OW2.5LBS-20MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm 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-200-18
In Commercial Distribution

  • M621OW25LBS18MM0 ()

  • 2.5mm x 18mm
OW2.5LBS-18MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 16mm 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-200-16
In Commercial Distribution

  • M621OW25LBS16MM0 ()

  • 2.5mm x 16mm
OW2.5LBS-16MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 14mm 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-200-14
In Commercial Distribution

  • M621OW25LBS14MM0 ()

  • 2.5mm x 14mm
OW2.5LBS-14MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
osteo-WEDGE 2.5mm x 12mm 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-200-12
In Commercial Distribution

  • M621OW25LBS12MM0 ()

  • 2.5mm x 12mm
OW2.5LBS-12MM

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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
HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizers (05mm thru 10mm), one Driver and three Guide Wires. For use with the HyProCure Sinus Tarsi Implant system. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Gramedica
HYP-INS-TRAY
In Commercial Distribution

  • M621HYPINSTRAY0 ()
HYP-INS-TRAY

  • Orthopaedic prosthesis implantation positioning instrument, reusable
HyProCure II Trial Sizer 12 instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
Gramedica
HYP II-TS-12
In Commercial Distribution

  • M621HYPIITS120 ()

  • Length: 18.20 Millimeter
HYP II-TS-12

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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