Gramedica

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- Catalog Number : HYP-INS-TRAY

Device Description : HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizer 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Device Description : Reusable HyProCure SinusTarsi Decompression Scissors for dissecting and cutting Reusable HyProCure SinusTarsi Decompression Scissors for dissecting and cutting soft tissue.

Device Class : 1

Duns Number: 828660345

Premarket Exempt : Yes

Product Code : HRR

Prescription Use : Yes

Device Count : 1

- Catalog Number : OT-SA

Device Description : The Opti-Toe-Small Angle Implant is comprised of two mated components (proximal The Opti-Toe-Small Angle Implant is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. Indications: The GraMedica opti-Toe Device is indicate for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect weight-bearing or heal bearing until healing has occurred.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

- Catalog Number : OT-SS

Device Description : The opti-Toe Small Straight Implant is comprised of two mated components (proxim The opti-Toe Small Straight Implant is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. Indications: The GraMedica opti-Toe Device is indicate for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect weight-bearing or heal bearing until healing has occurred.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Device Description : osteo-WEDGE Temporary Tack, 2.4mm x 12mm. Non-sterile single use (disposable) a 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : osteo-WEDGE 2.5mm x 08mm Locking Bone Screw. Non-sterile single use implant for 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : osteo-WEDGE 2.5mm x 10mm Locking Bone Screw. Non-sterile single use implant for 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : osteo-WEDGE 2.5mm x 12mm Locking Bone Screw. Non-sterile single use implant for 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : osteo-WEDGE 2.5mm x 14mm Locking Bone Screw. Non-sterile single use implant for 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : osteo-WEDGE 2.5mm x 16mm Locking Bone Screw. Non-sterile single use implant for 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1