Gramedica

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Plate, Fixation, Bone (HRS) (3) Screw, Fixation, Bone (HWC) (3)

Premarket Exempt

No Yes

Clear

osteo-WEDGE 3.0mm x 22mm Locking Bone Screw - M621OW30LBS22MM0 Catalog Number : OW3.0LBS-22MM

Device Description : osteo-WEDGE 3.0mm x 22mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 22mm 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

osteo-WEDGE 3.0mm x 24mm Locking Bone Screw - M621OW30LBS24MM0 Catalog Number : OW3.0LBS-24MM

Device Description : osteo-WEDGE 3.0mm x 24mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 24mm 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

osteo-WEDGE 3.0mm x 26mm Locking Bone Screw - M621OW30LBS26MM0 Catalog Number : OW3.0LBS-26MM

Device Description : osteo-WEDGE 3.0mm x 26mm Locking Bone Screw. Non-sterile single use implant for osteo-WEDGE 3.0mm x 26mm 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

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