Integra® Spider™ Limted Wrist Fusion System 062812

GUDID M2480628121

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

INTEGRA LIFESCIENCES CORPORATION

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

Primary Device ID	M2480628121
NIH Device Record Key	b0cf2ce4-093c-430a-87ef-6cc250df26b9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Integra® Spider™ Limted Wrist Fusion System
Version Model Number	062812
Catalog Number	062812
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
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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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.
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	10381780064701 [Primary]
HIBCC	M2480628121 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991873

FDA Product Code

HRS	Plate, Fixation, Bone