TiWedge™

GUDID M269TRL1006C061

The Integra Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure. Trial Cotton 20 X 6.5

Ascension Orthopedics, Inc.

Surgical implant template, reusable

• Primary Device ID: M269TRL1006C061
• NIH Device Record Key: a62a8403-a9d6-459a-baf2-e8f7e21a92f8
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TiWedge™
• Version Model Number: TRL-1006-C06
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780237686 [Primary]
HIBCC	M269TRL1006C061 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131360

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

[M269TRL1006C061]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-05-02
• Device Publish Date: 2016-08-08

On-Brand Devices [TiWedge™]

• M269INS1006001: The Integra® Titanium Bone Wedge Inserter is attached to the selected wedge implant and insert
• M269TRL1006C061: The Integra Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for an
• M269TRL1006C051: The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
• M269TRL1006C041: The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
• M269TRL1006C031: The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
• M269TRL1006C021: The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
• M269TRL1006C011: The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
• M269TRL1006L091: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L081: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L071: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L061: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L051: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L041: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L031: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L021: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
• M269TRL1006L011: The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim