The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Ultimax Distal Femoral Intramedullary Rod System.
| Device ID | K981230 |
| 510k Number | K981230 |
| Device Name: | ULTIMAX 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 | 1998-04-03 |
| Decision Date | 1998-06-01 |