TiWedgeTM

GUDID M268TIWEDGEINSTP1

The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot. This set includes LCL trials and cotton trials to evaluate proper size and fit of the implants. A wedge inserter and tamp are also included for assistance.

Ascension Orthopedics, Inc.

General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: M268TIWEDGEINSTP1
• NIH Device Record Key: 6e8f497b-11bb-4f0e-bdf7-0b97494e2915
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TiWedgeTM
• Version Model Number: TIWEDGEINSTP
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	10381780237471 [Primary]
HIBCC	M268TIWEDGEINSTP1 [Secondary]

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

[M268TIWEDGEINSTP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-13
• Device Publish Date: 2016-08-15

Devices Manufactured by Ascension Orthopedics, Inc.

• M268TIWEDGEINSTP1 - TiWedgeTM: 2023-11-13The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot. This set includes LCL trials and cotton trials to evaluate proper size and fit of the implants. A wedge inserter and tamp are also included for assistance.
• M268TIWEDGEINSTP1 - TiWedgeTM: 2023-11-13 The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle
• M269AW32051 - CAPTURE™: 2023-11-09 CAPTURE™ High Torque Screw System The cannula cleaning stylet is used to clean all cannulated instruments. This instrument is
• 10381780123026 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123033 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123040 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123057 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123064 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• M26922286111 - Integra®: 2023-09-18 Integra® Total Foot System K-Wire is used for temporary fixation.