Talon™ DistalFix™ ART Cortical Screw ART-5-035
GUDID B058ART50351
Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 035mm
Orthopedic Designs North America, Inc.
Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | B058ART50351 |
| NIH Device Record Key | fab5b09f-7ef0-406f-8922-d18ec03fbe6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Talon™ DistalFix™ ART Cortical Screw |
| Version Model Number | ART5035 |
| Catalog Number | ART-5-035 |
| Company DUNS | 945518848 |
| Company Name | Orthopedic Designs North America, 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 | 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 | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com |
Device Dimensions
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 35 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B058ART50351 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152295
FDA Product Code
| HSB | Rod, Fixation, Intramedullary And Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
[B058ART50351]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-07 |
| Device Publish Date | 2021-11-29 |
On-Brand Devices [Talon™ DistalFix™ ART Cortical Screw]
| B058ART51201 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 120mm |
| B058ART51151 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 115mm |
| B058ART51101 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 110mm |
| B058ART51051 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 105mm |
| B058ART51001 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 100mm |
| B058ART50951 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 095mm |
| B058ART50901 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 090mm |
| B058ART50851 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 085mm |
| B058ART50801 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 080mm |
| B058ART50751 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 075mm |
| B058ART50701 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 070mm |
| B058ART50651 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 065mm |
| B058ART50601 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 060mm |
| B058ART50551 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 055mm |
| B058ART50501 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 050mm |
| B058ART50451 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 045mm |
| B058ART50401 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 040mm |
| B058ART50351 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 035mm |
| B058ART50301 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 030mm |
| B058ART5055NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 055mm (non-sterile) |
| B058ART5050NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 050mm (non-sterile) |
| B058ART5045NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 045mm (non-sterile) |
| B058ART5040NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 040mm (non-sterile) |
| B058ART5035NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 035mm (non-sterile) |
| B058ART5030NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 030mm (non-sterile) |
| B058ART5095NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 095mm (non-sterile) |
| B058ART5090NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 090mm (non-sterile) |
| B058ART5085NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 085mm (non-sterile) |
| B058ART5080NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 080mm (non-sterile) |
| B058ART5075NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 075mm (non-sterile) |
| B058ART5070NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 070mm (non-sterile) |
| B058ART5065NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 065mm (non-sterile) |
| B058ART5060NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 060mm (non-sterile) |
| B058ART5120NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 120mm (non-sterile) |
| B058ART5115NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 115mm (non-sterile) |
| B058ART5110NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 110mm (non-sterile) |
| B058ART5105NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 105mm (non-sterile) |
| B058ART5100NS1 | Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 100mm (non-sterile) |
Trademark Results [Talon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TALON 98801808 not registered Live/Pending |
AirBorn, Inc. 2024-10-15 |
 TALON 98768729 not registered Live/Pending |
Four Season Industries, LLC 2024-09-25 |
 TALON 98422301 not registered Live/Pending |
Watershed Geosynthetics LLC 2024-02-26 |
 TALON 98380466 not registered Live/Pending |
ASSA ABLOY Entrance Systems AB 2024-01-29 |
 TALON 98375503 not registered Live/Pending |
Michael the Maven, LLC 2024-01-25 |
 TALON 98251906 not registered Live/Pending |
ASSA ABLOY Entrance Systems AB 2023-11-02 |
 TALON 98236420 not registered Live/Pending |
Mendocino Brewing Company, Inc. 2023-10-23 |
 TALON 98231715 not registered Live/Pending |
S. Rays, Inc. 2023-10-19 |
 TALON 98186815 not registered Live/Pending |
SunModo Corporation 2023-09-19 |
 TALON 97818330 not registered Live/Pending |
Traxxas, L.P. 2023-03-01 |
 TALON 97794808 not registered Live/Pending |
Talon Outdoor Limited 2023-02-14 |
 TALON 97709052 not registered Live/Pending |
Lockheed Martin Corporation 2022-12-08 |
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