TiWedge™

GUDID M269TRL1006C031

The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.

Ascension Orthopedics, Inc.

Surgical implant template, reusable

• Primary Device ID: M269TRL1006C031
• NIH Device Record Key: 5c30977b-509e-4eef-9795-2ee6ac72c96b
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TiWedge™
• Version Model Number: TRL-1006-C03
• 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	10381780237655 [Primary]
HIBCC	M269TRL1006C031 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131360

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

Moist Heat or Steam Sterilization

[M269TRL1006C031]

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