Universal 2™ Total Wrist System 263500RT

GUDID M268263500RT1

The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal.

INTEGRA LIFESCIENCES CORPORATION

Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis
Primary Device IDM268263500RT1
NIH Device Record Keyada6fdae-af01-4882-8295-d0128e7b90fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal 2™ Total Wrist System
Version Model Number263500RT
Catalog Number263500RT
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
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 Datetrue
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
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 Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780066149 [Primary]
HIBCCM268263500RT1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-26
Device Publish Date2017-10-09

On-Brand Devices [Universal 2™ Total Wrist System]

M268UNI2SET0The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists
M248264535S1The Universal 2 Total Wrist cancellous bone screw implant.
M248264530S1The Universal 2 Total Wrist cancellous bone screw implant.
M248264525S1The Universal 2 Total Wrist cancellous bone screw implant.
M248264520S1The Universal 2 Total Wrist cancellous bone screw implant.
M268263800RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M268263800LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M268263700RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M268263700LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M268263600RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M268263600LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M268263500RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M268263500LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263400RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263400LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263300RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263300LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263200RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263200LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263100RT1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M248263100LF1The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
M2482624021The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482624011The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482624001The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482623021The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482623011The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482623001The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482622021The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482622011The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482622001The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482621021The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482621011The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482621001The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
M2482614011The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
M2482613011The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
M2482612011The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
M2482611011The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
M2482645351The Universal 2 Total Wrist cancellous bone screw implant.
M2482645301The Universal 2 Total Wrist cancellous bone screw implant.
M2482645201The Universal 2 Total Wrist cancellous bone screw implant.
M248264515S1The Universal 2 Total Wrist cancellous bone screw implant.
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