The following data is part of a premarket notification filed by Orthopedic Designs, Inc. with the FDA for Odi Talon Intramedullary Hip Nail.
| Device ID | K014189 |
| 510k Number | K014189 |
| Device Name: | ODI TALON INTRAMEDULLARY HIP NAIL |
| Classification | Nail, Fixation, Bone |
| Applicant | ORTHOPEDIC DESIGNS, INC. 6965 1ST AVE., NORTH St. Petersburg, FL 33710 -8303 |
| Contact | John Sodeika |
| Correspondent | John Sodeika ORTHOPEDIC DESIGNS, INC. 6965 1ST AVE., NORTH St. Petersburg, FL 33710 -8303 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B058THN1352101 | K014189 | 000 |
| B058THN1302101 | K014189 | 000 |
| B058THN1252101 | K014189 | 000 |
| B058THN0011 | K014189 | 000 |