Kompressor™ Compression Screw System 210422

GUDID M2482104221

The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.

INTEGRA LIFESCIENCES CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: M2482104221
• NIH Device Record Key: 814dfc44-1baf-4fe0-a6f5-b313e21b79b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kompressor™ Compression Screw System
• Version Model Number: 210422
• Catalog Number: 210422
• 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: true
• Expiration Date: true
• 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
• 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.
• 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	10381780065623 [Primary]
HIBCC	M2482104221 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040356

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-26
• Device Publish Date: 2017-10-09

On-Brand Devices [Kompressor™ Compression Screw System]

• M2482116111: Kompressor™ Compression Screw System 2.2MM DRILL GUIDE
• M2482116101: Kompressor™ Compression Screw System 2.8MM DRILL GUIDE
• M2482116011: Kompressor™ Compression Screw System 2.5MM DRILL GUIDE
• M2482116001: Kompressor™ Compression Screw System 3.5MM DRILL GUIDE
• M2482150011: KOMPRESSOR STERILIZATION TRAY
• M2482103261: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482103241: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482103221: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482103201: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482103161: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482103141: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482103121: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482103101: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the
• M2482104341: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104321: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104301: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104281: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104261: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104241: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104221: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104201: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104181: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104161: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482104141: The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in
• M2482103181: The mini Kompressor Compression Screw is a two-piece fixation device intended for the use in the