TiWedge™

GUDID M269INS1006001

The Integra® Titanium Bone Wedge Inserter is attached to the selected wedge implant and inserted into the osteotomy and impact until fully seated.

Ascension Orthopedics, Inc.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: M269INS1006001
• NIH Device Record Key: b25017da-f339-40b6-a419-c67badbba501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiWedge™
• Version Model Number: INS-1006-00
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780237693 [Primary]
HIBCC	M269INS1006001 [Secondary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

[M269INS1006001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-08
• 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