The following data is part of a premarket notification filed by Orthopedic Designs North America, Inc. with the FDA for Talon Distalfix Proximal Femoral Nail.
| Device ID | K111352 |
| 510k Number | K111352 |
| Device Name: | TALON DISTALFIX PROXIMAL FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOPEDIC DESIGNS NORTH AMERICA, INC. 5912 BRECKENRIDGE PARKWAY SUITE F Tampa, FL 33610 |
| Contact | Seth Masek |
| Correspondent | Seth Masek 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B058SLN1550101 | K111352 | 000 |
| B058SLN12530L1 | K111352 | 000 |
| B058SLN1252201 | K111352 | 000 |
| B058SLN1202201 | K111352 | 000 |
| B058SLN0111201 | K111352 | 000 |
| B058SLN0111151 | K111352 | 000 |
| B058SLN0111101 | K111352 | 000 |
| B058SLN0111051 | K111352 | 000 |
| B058SLN0111001 | K111352 | 000 |
| B058SLN0110951 | K111352 | 000 |
| B058SLN0110901 | K111352 | 000 |
| B058SLN0110851 | K111352 | 000 |
| B058SLN0110801 | K111352 | 000 |
| B058SLN0110751 | K111352 | 000 |
| B058SLN12530R1 | K111352 | 000 |
| B058SLN12532L1 | K111352 | 000 |
| B058SLN12532R1 | K111352 | 000 |
| B058SLN1550051 | K111352 | 000 |
| B058SLN1550001 | K111352 | 000 |
| B058SLN1302201 | K111352 | 000 |
| B058SLN12542R1 | K111352 | 000 |
| B058SLN12542L1 | K111352 | 000 |
| B058SLN12540R1 | K111352 | 000 |
| B058SLN12540L1 | K111352 | 000 |
| B058SLN12538R1 | K111352 | 000 |
| B058SLN12538L1 | K111352 | 000 |
| B058SLN12536R1 | K111352 | 000 |
| B058SLN12536L1 | K111352 | 000 |
| B058SLN12534R1 | K111352 | 000 |
| B058SLN12534L1 | K111352 | 000 |
| B058SLN0110701 | K111352 | 000 |