The following data is part of a premarket notification filed by Orthopedic Designs, Inc. (odi) with the FDA for Odi Talon Long Proximal Femoral Nail System.
| Device ID | K033286 |
| 510k Number | K033286 |
| Device Name: | ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOPEDIC DESIGNS, INC. (ODI) 9521 INTERNATIONAL COURT NORTH St. Petersburg, FL 33716 |
| Contact | John Sodeika |
| Correspondent | John Sodeika ORTHOPEDIC DESIGNS, INC. (ODI) 9521 INTERNATIONAL COURT NORTH St. Petersburg, FL 33716 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2004-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B058THN135380R1 | K033286 | 000 |
| B058THN125340R1 | K033286 | 000 |
| B058THN125380L1 | K033286 | 000 |
| B058THN125380R1 | K033286 | 000 |
| B058THN130340L1 | K033286 | 000 |
| B058THN130340R1 | K033286 | 000 |
| B058THN130380L1 | K033286 | 000 |
| B058THN130380R1 | K033286 | 000 |
| B058THN135340L1 | K033286 | 000 |
| B058THN135340R1 | K033286 | 000 |
| B058THN135380L1 | K033286 | 000 |
| B058THN125340L1 | K033286 | 000 |