Talon™ DistalFix™ A/R Femoral Nail ART-11-380
GUDID B058ART113801
Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 380mm
Orthopedic Designs North America, Inc.
Femur nail, sterile| Primary Device ID | B058ART113801 |
| NIH Device Record Key | e0ec5f6d-3c34-4b0e-b0aa-5acf2bf7555e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Talon™ DistalFix™ A/R Femoral Nail |
| Version Model Number | ART11380 |
| Catalog Number | ART-11-380 |
| 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 | true |
| 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 |
Device Dimensions
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 380 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B058ART113801 [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 |
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
Moist Heat or Steam Sterilization
[B058ART113801]
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™ A/R Femoral Nail]
| B058ART124201 | Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 420mm |
| B058ART124001 | Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 400mm |
| B058ART123801 | Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 380mm |
| B058ART123601 | Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 360mm |
| B058ART123401 | Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 340mm |
| B058ART123201 | Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 320mm |
| B058ART114201 | Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 420mm |
| B058ART114001 | Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 400mm |
| B058ART113801 | Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 380mm |
| B058ART113601 | Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 360mm |
| B058ART113401 | Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 340mm |
| B058ART113201 | Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 320mm |
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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