Integra® Spider™ Limted Wrist Fusion System 072812

GUDID M2480728121

The Integra Spider Limited Wrist Fusion bone screw is used in assembly with the plate.

INTEGRA LIFESCIENCES CORPORATION

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Primary Device ID	M2480728121
NIH Device Record Key	a5b3ff01-10d2-473b-a86b-63cc78f34d61
Commercial Distribution Status	In Commercial Distribution
Brand Name	Integra® Spider™ Limted Wrist Fusion System
Version Model Number	072812
Catalog Number	072812
Company DUNS	963856096
Company Name	INTEGRA LIFESCIENCES CORPORATION
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	+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
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
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
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Operating and Storage Conditions

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.
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.
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	10381780064831 [Primary]
HIBCC	M2480728121 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991873

FDA Product Code

HRS	Plate, Fixation, Bone