Integra® Total Wrist Fusion System 303328
GUDID M2483033281
Total Wrist Fusion cortical screw
Ascension Orthopedics, Inc.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | M2483033281 |
| NIH Device Record Key | bd25cd3a-7301-4080-877c-66f7b3d3d9b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® Total Wrist Fusion System |
| Version Model Number | 303328 |
| Catalog Number | 303328 |
| 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
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 |
| 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 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780065388 [Primary] |
| HIBCC | M2483033281 [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 |
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
[M2483033281]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-04 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [Integra® Total Wrist Fusion System]
| M2483034021 | 2.7 MM DRILL BIT |
| M2483034011 | 2.5 MM DRILL BIT |
| M2483034001 | 2.0 MM DRILL BIT |
| M2483034521 | SHORT BEND PLATE TRIAL |
| M2483034511 | STANDARD BEND PLATE TRIAL |
| M2483034501 | STRAIGHT PLATE TRIAL |
| M2483034071 | DEPTH GAUGE |
| M2483034121 | PLATE BENDER 3.5 MM HOLE |
| M2483034111 | PLATE BENDER 2.7 MM HOLE |
| M2483034101 | 2.0 MM, SELF RETAINING HEX DRIVER |
| M2483034091 | 2.5 MM, SELF RETAINING HEX DRIVER |
| M2483034081 | SELF RETAINING STAR DRIVER |
| M2483034061 | 3.5MM THREADED DRILL GUIDE 2.7 MM DRILL BIT |
| M2483034051 | 2.7MM THREADED DRILL GUIDE 2.0 MM DRILL BIT |
| M2483034041 | CORTICAL DOUBLE ENDED DRILL GUIDE 2.5 MM DRILL BIT |
| M2483034031 | CORTICAL DOUBLE ENDED DRILL GUIDE 2.0 MM DRILL BIT |
| M2483033281 | Total Wrist Fusion cortical screw |
| M2483033161 | Total Wrist Fusion cortical screw |
| M2483033121 | Total Wrist Fusion cortical screw |
| M2483032121 | Total Wrist Fusion cortical screw |
| M2483032101 | Total Wrist Fusion cortical screw |
| M2483031011 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
| M2483031001 | The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws. |
Trademark Results [Integra]
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