Integra® Titanium Bone Wedge System TBW-1006-1655

GUDID 10381780124900

The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot

Ascension Orthopedics, Inc.

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• Primary Device ID: 10381780124900
• NIH Device Record Key: 5be4fd54-6336-4883-9fb5-d240377ccedd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Titanium Bone Wedge System
• Version Model Number: TBW-1006-1655
• Catalog Number: TBW-1006-1655
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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: false
• 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: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780124900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131360

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-06-08
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® Titanium Bone Wedge System]

• 10381780124948: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124931: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124924: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124917: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124900: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124894: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124887: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124870: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124863: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124856: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124849: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124832: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124825: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124818: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f
• 10381780124801: The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone f