Integra® Spider™ Limted Wrist Fusion System 072810
GUDID M2480728101
The Integra Spider Limited Wrist Fusion bone screw is used in assembly with the plate.
Ascension Orthopedics, Inc.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | M2480728101 |
| NIH Device Record Key | fcb005cb-7dd1-49fb-9b40-523e0c05be19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® Spider™ Limted Wrist Fusion System |
| Version Model Number | 072810 |
| Catalog Number | 072810 |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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 | 10381780064824 [Primary] |
| HIBCC | M2480728101 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991873
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
Moist Heat or Steam Sterilization
[M2480728101]
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® Spider™ Limted Wrist Fusion System]
| M248SPIDERIMP1 | SPIDER Implant Set |
| M2486007091 | 1.5MM DRILL BIT SOLID |
| M2486007041 | 2.0MM DRILL BIT SOLID |
| M2486007401 | TAP 3.5MM |
| M2486007261 | HEX DRIVER SLEEVE |
| M2486007241 | 2.5MM HEX DRIVER AO COUPLE |
| M2486007221 | 1.5/2.0MM DRILL GUIDE |
| M2486007211 | MINI SPIDER RASP |
| M2486007201 | SPIDER RASP |
| M2486007181 | T-HANDLE QUICK COUPLE for the Integra® Spider™ Limted Wrist Fusion System |
| M2486007161 | CLEANING BRUSH |
| M2480728181 | The Integra Spider Limited Wrist Fusion bone screw is used in assembly with the plate. |
| M2480728141 | The Integra Spider Limited Wrist Fusion bone screw is used in assembly with the plate. |
| M2480728101 | The Integra Spider Limited Wrist Fusion bone screw is used in assembly with the plate. |
Trademark Results [Integra]
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