The following data is part of a premarket notification filed by Orthopedic Designs North America, Inc. with the FDA for Talon Distalfix Antegrade/retrograde Femoral Nail.
| Device ID | K152295 |
| 510k Number | K152295 |
| Device Name: | Talon DistalFix Antegrade/Retrograde Femoral Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOPEDIC DESIGNS NORTH AMERICA, INC. 5912 BRECKENRIDGE PARKWAY SUITE F Tampa, FL 33610 |
| Contact | Robin Wilson |
| Correspondent | Robin Wilson ORTHOPEDIC DESIGNS NORTH AMERICA, INC. 5912 BRECKENRIDGE PARKWAY SUITE F Tampa, FL 33610 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-13 |
| Decision Date | 2015-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B058ART5100NS1 | K152295 | 000 |
| B058ART5040NS1 | K152295 | 000 |
| B058ART5045NS1 | K152295 | 000 |
| B058ART5050NS1 | K152295 | 000 |
| B058ART5055NS1 | K152295 | 000 |
| B058ART113201 | K152295 | 000 |
| B058ART113401 | K152295 | 000 |
| B058ART113601 | K152295 | 000 |
| B058ART113801 | K152295 | 000 |
| B058ART114001 | K152295 | 000 |
| B058ART114201 | K152295 | 000 |
| B058ART123201 | K152295 | 000 |
| B058ART5035NS1 | K152295 | 000 |
| B058ART5030NS1 | K152295 | 000 |
| B058ART5095NS1 | K152295 | 000 |
| B058ART5105NS1 | K152295 | 000 |
| B058ART5110NS1 | K152295 | 000 |
| B058ART5115NS1 | K152295 | 000 |
| B058ART5120NS1 | K152295 | 000 |
| B058ART5060NS1 | K152295 | 000 |
| B058ART5065NS1 | K152295 | 000 |
| B058ART5070NS1 | K152295 | 000 |
| B058ART5075NS1 | K152295 | 000 |
| B058ART5080NS1 | K152295 | 000 |
| B058ART5085NS1 | K152295 | 000 |
| B058ART5090NS1 | K152295 | 000 |
| B058ART123401 | K152295 | 000 |
| B058ART123601 | K152295 | 000 |
| B058ART50651 | K152295 | 000 |
| B058ART50701 | K152295 | 000 |
| B058ART50751 | K152295 | 000 |
| B058ART50801 | K152295 | 000 |
| B058ART50851 | K152295 | 000 |
| B058ART50901 | K152295 | 000 |
| B058ART50951 | K152295 | 000 |
| B058ART51001 | K152295 | 000 |
| B058ART51051 | K152295 | 000 |
| B058ART51101 | K152295 | 000 |
| B058ART51151 | K152295 | 000 |
| B058ART50601 | K152295 | 000 |
| B058ART50551 | K152295 | 000 |
| B058ART50501 | K152295 | 000 |
| B058ART123801 | K152295 | 000 |
| B058ART124001 | K152295 | 000 |
| B058ART124201 | K152295 | 000 |
| B058ART13C001 | K152295 | 000 |
| B058ART13C051 | K152295 | 000 |
| B058ART13C101 | K152295 | 000 |
| B058ART13C151 | K152295 | 000 |
| B058ART50301 | K152295 | 000 |
| B058ART50351 | K152295 | 000 |
| B058ART50401 | K152295 | 000 |
| B058ART50451 | K152295 | 000 |
| B058ART51201 | K152295 | 000 |