Universal 2™ Total Wrist System 264515

GUDID M2482645151

The Universal 2 Total Wrist cancellous bone screw implant.

Ascension Orthopedics, Inc.

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 ID	M2482645151
NIH Device Record Key	23cab848-7627-4b00-85ca-1dfd407eed61
Commercial Distribution Status	In Commercial Distribution
Brand Name	Universal 2™ Total Wrist System
Version Model Number	264515
Catalog Number	264515
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	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@integralife.com
Phone	800-654-2873
Email	custsvnj@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 Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780064879 [Primary]
HIBCC	M2482645151 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K030037

FDA Product Code

JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained