Integra® Ti6® Internal Fixation System TI6LOPROIMP

GUDID M268TI6LOPROIMP1

The Integra Ti6 Internal Fixation System is comprised of Low Profile screws used for bone fixation of the hand and foot following trauma or osteotomy. The low profile screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0 and 4.0 diameters with lengths of 2.0, 2.5, 3.0, and 4.0. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDM268TI6LOPROIMP1
NIH Device Record Key9152a170-2329-42b2-8c3f-1cda732d74df
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra® Ti6® Internal Fixation System
Version Model NumberTI6LOPROIMP
Catalog NumberTI6LOPROIMP
Company DUNS942377524
Company NameAscension Orthopedics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780074328 [Primary]
HIBCCM268TI6LOPROIMP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


[M268TI6LOPROIMP1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-16
Device Publish Date2015-09-22

On-Brand Devices [Integra® Ti6® Internal Fixation System]

M268TI6SOLIDIMP1The Integra Ti6 Internal Fixation System is comprised of Solid Bone screws used for bone fixat
M268TI6LOPROIMP1The Integra Ti6 Internal Fixation System is comprised of Low Profile screws used for bone fixati
M268TI6HLESSIMP1The Integra Ti6 Internal Fixation System is comprised of Headless screws used for bone fixation
M268TI6DIGITIMP1The Integra Ti6 Internal Fixation System is comprised of Digital screws used for bone fixation o

Trademark Results [Integra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEGRA
INTEGRA
98465614 not registered Live/Pending
Cleveland-Cliffs Inc.
2024-03-25
INTEGRA
INTEGRA
98382495 not registered Live/Pending
Universal Instruments Corporation
2024-01-30
INTEGRA
INTEGRA
98155011 not registered Live/Pending
Integra Mission Critical, LLC
2023-08-29
INTEGRA
INTEGRA
97870354 not registered Live/Pending
CROWN PACKAGING TECHNOLOGY, INC.
2023-04-03
INTEGRA
INTEGRA
97711737 not registered Live/Pending
Honda Motor Co., Ltd.
2022-12-09
INTEGRA
INTEGRA
97640152 not registered Live/Pending
Integra LifeSciences Corporation
2022-10-20
INTEGRA
INTEGRA
97636638 not registered Live/Pending
POLYSOURCE, INC.
2022-10-18
INTEGRA
INTEGRA
97060638 not registered Live/Pending
Nordson Corporation
2021-10-05
INTEGRA
INTEGRA
90894598 not registered Live/Pending
Honda Motor Co. Ltd.
2021-08-20
INTEGRA
INTEGRA
90880335 not registered Live/Pending
Honda Motor Co. Ltd.
2021-08-12
INTEGRA
INTEGRA
88947894 not registered Live/Pending
Horton Point LLC
2020-06-04
INTEGRA
INTEGRA
88794888 not registered Live/Pending
Interior Design Group
2020-02-12

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