osteo-WEDGE2 9 Degree Angulated Bone Plate Implant, Small GM-503-09

GUDID M621GM503090

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.

GRAHAM MEDICAL TECHNOLOGIES, L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Primary Device ID	M621GM503090
NIH Device Record Key	91217520-df5e-438e-87c2-6d0c48fa179b
Commercial Distribution Status	In Commercial Distribution
Brand Name	osteo-WEDGE2 9 Degree Angulated Bone Plate Implant, Small
Version Model Number	GM-503-09
Catalog Number	GM-503-09
Company DUNS	828660345
Company Name	GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M621GM503090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162179

FDA Product Code

HRS	Plate, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

[M621GM503090]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-03-25
Device Publish Date	2020-03-17

Devices Manufactured by GRAHAM MEDICAL TECHNOLOGIES, L.L.C.

M621CARRYINGCASE20 - osteo-WEDGE2 Open Wedge Bone Locking System	2020-03-25 osteo-WEDGE2 Opening Wedge Bone Locking System -Kit (containing non-sterile single use implants (2.5mm locking bone screws, 3.0m
M621GM160030 - osteo-WEDGE2 Drill Guide	2020-03-25 osteo-WEDGE2 Drill Guide, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The os
M621GM160040 - osteo-WEDGE2 Drill Guide	2020-03-25 osteo-WEDGE2 Drill Guide, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The os
M621GM503000 - osteo-WEDGE2 0 Degree, Flat Bone Plate Implant, Small	2020-03-25 The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patie
M621GM503060 - osteo-WEDGE2 6 Degree Angulated Bone Plate Implant, Small	2020-03-25 The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patie
M621GM503090 - osteo-WEDGE2 9 Degree Angulated Bone Plate Implant, Small	2020-03-25The 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.
M621GM503090 - osteo-WEDGE2 9 Degree Angulated Bone Plate Implant, Small	2020-03-25 The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patie
M621GM503120 - osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Small	2020-03-25 The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patie
M621GM503150 - osteo-WEDGE2 15 Degree Angulated Bone Plate Implant, Small	2020-03-25 The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patie

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