osteo-WEDGE2 Drill Guide GM-160-04

GUDID M621GM160040

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.

GRAHAM MEDICAL TECHNOLOGIES, L.L.C.

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

• Primary Device ID: M621GM160040
• NIH Device Record Key: 8b56e5a3-2c50-4a33-9935-4bb02da88c46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osteo-WEDGE2 Drill Guide
• Version Model Number: GM-160-04
• Catalog Number: GM-160-04
• 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: false
• 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	M621GM160040 [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

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

Moist Heat or Steam Sterilization

[M621GM160040]

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

On-Brand Devices [osteo-WEDGE2 Drill Guide]

• M621GM160040: osteo-WEDGE2 Drill Guide, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bon
• M621GM160030: osteo-WEDGE2 Drill Guide, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bon