TiWedge™

GUDID M269TRL1006C061

The Integra Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure. Trial Cotton 20 X 6.5

Ascension Orthopedics, Inc.

Surgical implant template, reusable
Primary Device IDM269TRL1006C061
NIH Device Record Keya62a8403-a9d6-459a-baf2-e8f7e21a92f8
Commercial Distribution Discontinuation2023-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTiWedge™
Version Model NumberTRL-1006-C06
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 Usefalse
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
GS110381780237686 [Primary]
HIBCCM269TRL1006C061 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


[M269TRL1006C061]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-05-02
Device Publish Date2016-08-08

On-Brand Devices [TiWedge™]

M269INS1006001The Integra® Titanium Bone Wedge Inserter is attached to the selected wedge implant and insert
M269TRL1006C061The Integra Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for an
M269TRL1006C051The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
M269TRL1006C041The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
M269TRL1006C031The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
M269TRL1006C021The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
M269TRL1006C011The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the
M269TRL1006L091The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L081The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L071The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L061The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L051The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L041The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L031The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L021The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim
M269TRL1006L011The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim

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