Integra®Ti6® TH3028

GUDID 10381780115458

Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

Primary Device ID	10381780115458
NIH Device Record Key	2b7fa704-e2ea-45e8-9855-bd2c4484fce5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Integra®Ti6®
Version Model Number	TH3028
Catalog Number	TH3028
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780115458 [Primary]
HIBCC	M268TH30281 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K060026

FDA Product Code

HWC	Screw, fixation, bone