Gramedica

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- Catalog Number : GM-504-27

Device Description : The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and tr 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-504-30

Device Description : The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and tr 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-DS-LL

Device Description : Reusable Graham Decompression Scissors, curved left, for cutting soft tissue.

Device Class : 1

Duns Number: 828660345

Premarket Exempt : Yes

Product Code : HRR

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-DS-LR

Device Description : Reusable Graham Decompression Scissors, curved right, for cutting soft tissue.

Device Class : 1

Duns Number: 828660345

Premarket Exempt : Yes

Product Code : HRR

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-DS-LS

Device Description : Reusable Graham Decompression Scissors, straight, for cutting soft tissue.

Device Class : 1

Duns Number: 828660345

Premarket Exempt : Yes

Product Code : HRR

Prescription Use : Yes

Device Count : 1

- Catalog Number : HD-5-FG

Device Description : HyProCure Driver. Reusable instrument, for use with the HyProCure Sinus Tarsi HyProCure Driver. 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 : HYP-05

Device Description : HyProCure Sinus Tarsi Implant Size 05. Indications: HyProCure is a talotarsal HyProCure Sinus Tarsi Implant Size 05. 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 : HYP-06

Device Description : HyProCure Sinus Tarsi Implant Size 06. Indications: HyProCure is a talotarsal HyProCure Sinus Tarsi Implant Size 06. 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 : HYP-07

Device Description : HyProCure Sinus Tarsi Implant Size 07. Indications: HyProCure is a talotar HyProCure Sinus Tarsi Implant Size 07. 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 : HYP-08

Device Description : HyProCure Sinus Tarsi Implant Size 08. Indications: HyProCure is a talotarsa HyProCure Sinus Tarsi Implant Size 08. 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