The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Bti Distal Femoral Intramedullary Rod System.
| Device ID | K970897 |
| 510k Number | K970897 |
| Device Name: | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Contact | Danny Hodgeman |
| Correspondent | Danny Hodgeman BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-11 |
| Decision Date | 1997-04-21 |