Integra® External Fixation System 12225210

GUDID 10381780125419

The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features one distal end which is designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.

Ascension Orthopedics, Inc.

External orthopaedic fixation system, reusable
Primary Device ID10381780125419
NIH Device Record Key1cc8c922-2964-4cc0-a481-6c327a1ae278
Commercial Distribution Discontinuation2023-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIntegra® External Fixation System
Version Model Number12225210
Catalog Number12225210
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780125419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


[10381780125419]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-02
Device Publish Date2017-10-09

On-Brand Devices [Integra® External Fixation System]

M268XFIX4RCKRIMP1The Integra External Fixation System set consists of rings, footplates, anterior cross bars, and
10381780125679The Integra External Fixation System two-post bridge is manufactured from stainless steel. It is
10381780125426The strut is an adjustable component designed to facilitate building and maintaining frames, fro
10381780125419The strut is an adjustable component designed to facilitate building and maintaining frames, fro
M268XFIX5RINGIMP1The Integra External Fixation System set consists of rings and footplates. These devices are use
M268XFIX2RODSIMP1The Integra External Fixation System set consists of struts, rods, and hex posts. These devices
M268XFIX1BOLTIMP1The Integra External Fixation System set consists of wires, half-pins, nuts, and bolts. Instrume
10381780125402The strut is an adjustable component designed to facilitate building and maintaining frames, fro

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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