Integra® TruArch® TA1100

GUDID 10381780119968

The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot.

Ascension Orthopedics, Inc.

Subtalar implant, non-bioabsorbable

• Primary Device ID: 10381780119968
• NIH Device Record Key: 9eaab988-4fb3-473f-9d3c-a8f99bd53e8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® TruArch®
• Version Model Number: TA1100
• Catalog Number: TA1100
• 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

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 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	10381780119968 [Primary]
HIBCC	M268TA11001 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111265

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

[10381780119968]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® TruArch®]

• M268TRUARCHIMP1: The Integra TruArch subtalar implant is a one-piece titanium implant for treating hyperpronation
• 10381780119975: The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona
• 10381780119968: The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona
• 10381780119951: The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona
• 10381780119944: The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona
• 10381780119937: The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona
• M269TA30121: The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of
• M269TA30111: The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of
• M269TA30091: The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of
• M269TA30081: The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of
• M269TA30101: The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of