Gramedica

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- Catalog Number : GM-150-03

Device Description : osteo-WEDGE Driver, a reusable instrument, for use with the osteo-WEDGE Opening osteo-WEDGE Driver, 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-150-04

Device Description : osteo-WEDGE Screw Retainer Sleeve, a reusable instrument, for use with the oste osteo-WEDGE Screw Retainer 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-160-01

Device Description : osteo-WEDGE Drill Guide, a reusable instrument, for use with the osteo-WEDGE Op osteo-WEDGE Drill Guide, 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-160-03

Device Description : osteo-WEDGE2 Drill Guide, a reusable instrument, for use with the osteo-WEDGE O osteo-WEDGE2 Drill Guide, 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-160-04

Device Description : osteo-WEDGE2 Drill Guide, a reusable instrument, for use with the osteo-WEDGE O osteo-WEDGE2 Drill Guide, 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-501-00

Device Description : osteo-WEDGE Bone Plate 00mm. Non-sterile single use implant for use with the os 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-501-02

Device Description : osteo-WEDGE Bone Plate 02mm. Non-sterile single use implant for use with the os 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-501-04

Device Description : osteo-WEDGE Bone Plate 04mm. Non-sterile single use implant for use with the os 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-501-06

Device Description : osteo-WEDGE Bone Plate 06mm. Non-sterile single use implant for use with the os 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : GM-501-08

Device Description : osteo-WEDGE Bone Plate 08mm. Non-sterile single use implant for use with the os 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1