Integra® Total Wrist Fusion System 303320
GUDID M2483033201
Total Wrist Fusion cortical screw
INTEGRA LIFESCIENCES CORPORATION
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | M2483033201 |
| NIH Device Record Key | 5314b91b-4292-4f1f-8f6a-a6c5339ffb2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® Total Wrist Fusion System |
| Version Model Number | 303320 |
| Catalog Number | 303320 |
| 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 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
| 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 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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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 |
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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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780065340 [Primary] |
| HIBCC | M2483033201 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093163
FDA Product Code
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
[M2483033201]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-01 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [Integra® Total Wrist Fusion System]
| M2483035111 | INSTRUMENT CASE BASE (EMEA) |
| M2483035101 | INSTRUMENT CASE COMPLETE - EMEA |
| M2483035051 | INSTRUMENT CASE IMPLANT CADDY LID (US) |
| M2483035041 | INSTRUMENT CASE LID (US/EMEA) |
| M2483035031 | INSTRUMENT CASE IMPLANT CADDY (US) |
| M2483035021 | INSTRUMENT CASE TOP LEVEL (US/EMEA) |
| M2483035011 | INSTRUMENT CASE BASE (US) |
| M2483035001 | INSTRUMENT CASE COMPLETE - US |
| M248303328CS1 | Total Wrist Fusion cortical screw |
| M248303326CS1 | Total Wrist Fusion cortical screw |
| M248303324CS1 | Total Wrist Fusion cortical screw |
| M248303322CS1 | Total Wrist Fusion cortical screw |
| M248303320CS1 | Total Wrist Fusion cortical screw |
| M248303318CS1 | Total Wrist Fusion cortical screw |
| M248303316CS1 | Total Wrist Fusion cortical screw |
| M248303314CS1 | Total Wrist Fusion cortical screw |
| M248303312CS1 | Total Wrist Fusion cortical screw |
| M248303224CS1 | Total Wrist Fusion cortical screw |
| M248303222CS1 | Total Wrist Fusion cortical screw |
| M248303220CS1 | Total Wrist Fusion cortical screw |
| M248303218CS1 | Total Wrist Fusion cortical screw |
| M248303216CS1 | Total Wrist Fusion cortical screw |
| M248303214CS1 | Total Wrist Fusion cortical screw |
| M248303212CS1 | Total Wrist Fusion cortical screw |
| M248303210CS1 | Total Wrist Fusion cortical screw |
| M248303102S1 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
| M248303101S1 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
| M248303100S1 | The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws. |
| M2483033261 | Total Wrist Fusion cortical screw |
| M2483033241 | Total Wrist Fusion cortical screw |
| M2483033221 | Total Wrist Fusion cortical screw |
| M2483033181 | Total Wrist Fusion cortical screw |
| M2483033141 | Total Wrist Fusion cortical screw |
| M2483032241 | Total Wrist Fusion cortical screw |
| M2483032221 | Total Wrist Fusion cortical screw |
| M2483032201 | Total Wrist Fusion cortical screw |
| M2483032181 | Total Wrist Fusion cortical screw |
| M2483032161 | Total Wrist Fusion cortical screw |
| M2483032141 | Total Wrist Fusion cortical screw |
| M2483031021 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
| M2483033201 | Total Wrist Fusion cortical screw |
| M268WRISTFUSESET0 | The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight hol |
Trademark Results [Integra]
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