The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Ultimax Distal Radial (volar) Locking Plate System.
| Device ID | K990481 |
| 510k Number | K990481 |
| Device Name: | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-16 |
| Decision Date | 1999-03-17 |