Gramedica

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- Catalog Number : CarryingCase

Device Description : osteo-WEDGE Opening Wedge Bone Locking System -Kit (containing non-sterile singl osteo-WEDGE 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : CarryingCase2

Device Description : osteo-WEDGE2 Opening Wedge Bone Locking System -Kit (containing non-sterile sing 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP15-05-FG

Device Description : HyProCure Sizer 05. Reusable instrument, for use with the HyProCure Sinus Tarsi HyProCure Sizer 05. Reusable instrument, 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP15-06-FG

Device Description : HyProCure Sizer 06. Reusable instrument, for use with the HyProCure Sinus Tar HyProCure Sizer 06. Reusable instrument, 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP15-07-FG

Device Description : HyProCure Sizer 07. Reusable instrument, for use with the HyProCure Sinus Tars HyProCure Sizer 07. Reusable instrument, 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP15-08-FG

Device Description : HyProCure Sizer 08. Reusable instrument, for use with the HyProCure Sinus Tars HyProCure Sizer 08. Reusable instrument, 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP15-09-FG

Device Description : HyProCure Sizer 09. Reusable instrument, for use with the HyProCure Sinus Tars HyProCure Sizer 09. Reusable instrument, 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP15-10-FG

Device Description : HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tar HyProCure Sizer 10. Reusable instrument, 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-150-01

Device Description : osteo-WEDGE Depth Gauge Sleeve, a reusable instrument, for use with the osteo-WE osteo-WEDGE Depth Gauge 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-150-02

Device Description : osteo-WEDGE Depth Gauge, a reusable instrument, for use with the osteo-WEDGE Op osteo-WEDGE Depth Gauge, 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1