Integra® XT LJV182T

GUDID 10381780366393

Talar Dome, Sloped, Size 2, Right

Ascension Orthopedics, Inc.

Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis

• Primary Device ID: 10381780366393
• NIH Device Record Key: e3e9c283-9181-4895-9fd6-cff22d4c60ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® XT
• Version Model Number: LJV182T
• Catalog Number: LJV182T
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03700386955938 [Previous]
GS1	10381780366393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153452

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-03-29
• Device Publish Date: 2017-05-04

On-Brand Devices [Integra® XT]

• 10381780374077: Integra XT, Revision Instrument Case 1
• 10381780374060: Salto Talaris, Caddy Lid
• 10381780366447: Talar Dome, Sloped, Size 3, Left
• 10381780366430: Talar Dome, Sloped, Size 2, Left
• 10381780366423: Talar Dome, Sloped, Size 1, Left
• 10381780366416: Talar Dome, Sloped, Size 0, Left
• 10381780366409: Talar Dome, Sloped, Size 3, Right
• 10381780366393: Talar Dome, Sloped, Size 2, Right
• 10381780366386: Talar Dome, Sloped, Size 1, Right
• 10381780366379: Talar Dome, Sloped, Size 0, Right
• 10381780366362: Tibial Tray, 35mm Fin, TH10, Size 3
• 10381780366355: Tibial Tray, 35mm Fin, TH10, Size 2
• 10381780366348: Tibial Tray, 35mm Fin, TH10, Size 1
• 10381780366331: Tibial Tray, 35mm Fin, TH10, Size 0
• 10381780366324: Tibial Tray, 35mm Fin, TH4, Size 3
• 10381780366317: Tibial Tray, 35mm Fin, TH4, Size 2
• 10381780366300: Tibial Tray, 35mm Fin, TH4, Size 1
• 10381780366294: Tibial Tray, 35mm Fin, TH4, Size 0
• 10381780368885: Assembly spacer for thick tibia
• 10381780368878: In situ Poly inserter
• 10381780368854: Punching tip
• 10381780368830: Tibial holder
• 10381780368632: Stabilization Peg
• 10381780368441: Joint Distractor, Left
• 10381780368434: Joint Distractor, Right
• 10381780368731: Tibial trial rasp Size 2, Thick
• 10381780368724: Tibial trial rasp Size 1, Thick
• 10381780368717: Tibial trial rasp Size 0, Thick
• 10381780368663: Insert assembly bench, Long Fin
• 10381780368748: Tibial trial rasp Size 3, Thick