Integra®Ti6® TC2010

GUDID 10381780114796

Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone screw used in the Integra® Ti6® Internal Fixation System

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780114796
• NIH Device Record Key: 93c48dbb-aab2-4eff-b9fb-dcfbeecc8d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®Ti6®
• Version Model Number: TC2010
• Catalog Number: TC2010
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780114796 [Primary]
HIBCC	M268TC20101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060026

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

[10381780114796]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-15
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra®Ti6®]

• M269KW11051: Integra® Ti6® The Ti6 TH-Series K-Wire is used for temporary fixation.
• M269KW11041: Integra® Ti6® The Ti6 TC-Series Threaded K-Wire is used for temporary fixation.
• M269KW11031: Integra® Ti6® The Ti6 TC-Series K-Wire is used for temporary fixation.
• M269KW11021: Integra® Ti6® The Ti6 TC-Series K-Wire is used for temporary fixation.
• M269FS50101: Integra® Ti6® The 3-prong driver shaft is used to create holes in conjunction with the Ti6 TQ-
• M269FS40301: Integra® Ti6® The cannulated relief drill is used with the TH-series screws.
• M269FS40201: Integra® Ti6® The TH-Series cannulated depth gauge is a tool used to measure the depth of a dr
• M269FS40101: Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6
• M269FS30501: Integra® Ti6® The cannulated overdrill is used with the TC-series 3.0/4.0 mm screws.
• M269FS30421: Integra® Ti6® The cannulated drill is used with the TC-series 2.0/2.5 mm screws.
• M269FS30401: Integra® Ti6® The combination cannulated Countersink and Depth Gauge allows for precise measur
• M269FS30301: Integra® Ti6® The combination cannulated Countersink and Depth Gauge allows for precise measur
• M269FS30201: Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6
• M269FS30101: Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6
• M269FS10061: Integra® The handle is used to assist in orthopedic surgery.
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