osteo-WEDGE Depth Gauge Sleeve GM-150-01

GUDID M621GM150010

osteo-WEDGE Depth Gauge 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.

Gramedica

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

• Primary Device ID: M621GM150010
• NIH Device Record Key: 86b6d3d2-c169-4175-bd4f-3a55765f5dca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osteo-WEDGE Depth Gauge Sleeve
• Version Model Number: GM-150-01
• Catalog Number: GM-150-01
• Company DUNS: 828660345
• Company Name: Gramedica
• 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

Customer Support Contacts

• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx
• Phone: 586-677-9600
• Email: xx@xx.xx

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M621GM150010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111326

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

[M621GM150010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-26
• Device Publish Date: 2017-04-04

Devices Manufactured by Gramedica

• M621CARRYINGCASE0 - osteo-WEDGE Opening Wedge Bone Locking System: 2021-10-26 osteo-WEDGE Opening Wedge Bone Locking System -Kit (containing non-sterile single use implants (2.5mm locking bone screws, 3.0mm
• M621CP1505FG0 - HyProCure Sizer 05: 2021-10-26 HyProCure Sizer 05. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1506FG0 - HyProCure Sizer 06: 2021-10-26 HyProCure Sizer 06. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is
• M621CP1507FG0 - HyProCure Sizer 07: 2021-10-26 HyProCure Sizer 07. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1508FG0 - HyProCure Sizer 08: 2021-10-26 HyProCure Sizer 08. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1509FG0 - HyProCure Sizer 09: 2021-10-26 HyProCure Sizer 09. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
• M621CP1510FG0 - HyProCure Sizer 10: 2021-10-26 HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is
• M621GM150010 - osteo-WEDGE Depth Gauge Sleeve: 2021-10-26osteo-WEDGE Depth Gauge 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.
• M621GM150010 - osteo-WEDGE Depth Gauge Sleeve: 2021-10-26 osteo-WEDGE Depth Gauge Sleeve, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System.