The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Bti Cortical Bone Screws.
| Device ID | K972403 |
| 510k Number | K972403 |
| Device Name: | BTI CORTICAL BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Contact | Danny Hodgeman |
| Correspondent | Danny Hodgeman BIODYNAMIC TECHNOLOGIES, INC. EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-08-29 |